MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C1040
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra coil 400 (pc400) pusher assembly of the pc400 was fractured approximately 8.0 cm from the proximal end.Conclusions: evaluation of the returned penumbra coil 400 (pc400) pusher assembly and penumbra coil detachment handle (handle) revealed that the proximal pusher assembly hypotube was protruding through the nose cone funnel hole, plastic from the inner lumen of the cone had sheared, and the pet lock was separated.These types of damages can occur if the pc400 pusher assembly is forcefully inserted into the handle.The pusher assembly outer diameter (od) is larger than the inner lumen of the nose cone funnel hole and, by design, would result in the pc400 seating properly in the handle to detach a coil.If the pusher assembly is forcefully inserted into the handle pass the location of proper seating, damage such as this may occur.This is likely what caused the inability to remove the pusher assembly from the handle.Further evaluation revealed that the pusher assembly was fractured near the proximal end protruding out of the handle.This damage likely occurred from forceful manipulation of the pc400 in an attempt to remove the pusher assembly from the handle.The px slim delivery microcatheter (px slim) mentioned in the complaint was not returned for evaluation.Penumbra coils and handles are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2017-01287.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra coil 400s (pc400's) and a penumbra coil detachment handle (handle).During the procedure, the physician deployed and detached an initial pc400 into the target vessel using a px slim delivery microcatheter (px slim) and the handle.The physician then attempted to remove the pc400 pusher assembly from the handle but was unable to do so.Therefore, the handle was removed with the pusher assembly still stuck inside.The procedure was then completed using additional pc400's, a new handle, and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6769201
• Report Number: 3005168196-2017-01288
• Device Sequence Number: 1490718
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/04/2024
• Device Catalogue Number: 4002C1040
• Device Lot Number: F71953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1