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

Catalog Number	4004C1440
Medical Device Problem Codes	Bent (1059); Break (1069); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pc400 was fractured approximately 35.0 cm from the proximal end.The distal fracture portion of the pusher assembly was kinked approximately 153.0 from the proximal end when the fractured pieces were positioned together to exhibit the full effective length of the device.The embolization coil was detached from the pusher assembly and the sr wire was intact.Conclusions: evaluation of the returned pc400 revealed a fractured pusher assembly and detached embolization coil.If the pc400 is forcefully advanced against resistance the device may become kinked.Further manipulation of a kinked pusher assembly can result in the eventual fracture of the device.This pusher assembly fracture would allow the pull wire to be retracted from the distal detachment tip (ddt) and release the embolization coil.Further evaluation revealed a kink on the distal pusher assembly.This damage was likely incidental and occurred during packaging for return to penumbra.The root cause of the initial resistance could not be determined.Penumbra coils 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a ruptured aneurysm in the anterior communicating artery (acom) using penumbra coils 400 (pc400s).During the procedure, while attempting to introduce a pc400 into the px slim delivery microcatheter (px slim), the physician experienced resistance and subsequently, the pc400 pusher assembly became bent then broke; therefore, it was removed.The procedure was completed using 11 pc400s 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: 7022356
• Report Number: 3005168196-2017-02015
• Device Sequence Number: 16406766
• Product Code: HCG
• UDI-Device Identifier: 00814548011059
• UDI-Public: 00814548011059
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

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: 07/31/2021
• Device Catalogue Number: 4004C1440
• Device Lot Number: F37108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR