Op by Op — Steerable Catheter — Distal Tip

Distal Tip Bonding Operation

113-6399 · MPI-4471 · version 1 draft

Op 1 · Apply UV adhesive and bond distal tip to shaft

Operator dispenses metered UV adhesive at the joint and seats the tip.

CTQ Bond fully cured and continuous around the joint

Why it's critical: A partial cure or gap is the only way this step can send a latent defect downstream.

Failure mode Incomplete UV cure (insufficient dose / shadowed joint)

Hazardous situation: Tip separates from shaft during navigation
Why: An under-cured bond can hold on the bench but fail under vascular tortuosity loads.
Harm: Retained fragment / vessel injury requiring intervention

Mitigations & evidence:
  • • Calibrated UV dose with joint rotation; in-line dose verification
    Evidence: DOE showed full cure across the dose window with rotation; verified per-unit by the UV sensor.
  • • 100% post-bond tensile proof test
    Evidence: Proof load exceeds worst-case in-vivo tensile per the design input.
OSDRPN
pre596 270
post292 36

Severity rationale: Separation can cause a retained fragment — high harm.

Op 2 · Load assembly into fixture

Assembly is seated in a keyed fixture before the next operation.

CTQ Assembly seated in the correct orientation poka-yoke

Why it's critical: The fixture is keyed — a mis-oriented part physically cannot seat, so orientation is mistake-proofed.