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

Catalog Number	4004C0406
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 coil (pc400 coil) pusher assembly; the pusher assembly was kinked 24.0 cm from the proximal end and fractured approximately 25.0 cm; the proximal constraint sphere was intact with the distal detachment tip (ddt) with a piece of fractured stretch resistant wire (sr wire).The outer diameter (od) of the pusher assembly was measured and found to be within specification.Conclusions: evaluation of the returned device revealed the embolization coil's sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the device was forcefully retracted against resistance, damage such as this may occur.Further evaluation revealed the pusher assembly was kinked and fractured.This type of damage typically occurs due to forceful advancement of the pc400 coil against resistance.The damage found on the pusher assembly and sr wire was not mentioned in the complaint.The od of the pusher assembly was measured and found to be within specification.The coil was not returned and, therefore, the od of the coil was not measured.Due to the embolization coil not being returned and the damage found on the pc400 coil, the root cause of the complaint could not be determined.Pc400 coils are 100% functionally tested during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 coils (pc400 coils).During the procedure, the physician was unable to advance a pc400 coil into the px slim delivery microcatheter (px slim).The pc400 coil was removed and the procedure was completed using twelve new pc400 coils 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: 5391876
• Report Number: 3005168196-2016-00094
• Device Sequence Number: 382952
• Product Code: HCG
• UDI-Device Identifier: 00814548011684
• UDI-Public: 00814548011684
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Report Date (Section B): 12/29/2015

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: 07/31/2020
• Device Catalogue Number: 4004C0406
• Device Lot Number: F64735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1