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

Catalog Number	4006U0305
Medical Device Problem Codes	Detachment Of Device Component (1104); Out-Of-Box Failure (2311); Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The pusher assembly was kinked and fractured in multiple locations and the introducer sheath was kinked in multiple locations.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned device revealed that the pusher assembly was fractured and kinked in multiple locations and the introducer sheath was kinked in multiple locations.These damages were likely incidental and likely occurred during packaging for return to penumbra.Due to the incidental damages observed on the pc400 and due to the embolization coil not being returned for evaluation, the root cause of the reported unintentional detachment 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
During preparation for a coil embolization procedure, the hospital staff noticed that a penumbra coil 400 (pc400) had unintentionally detached from its pusher assembly upon removal from the dispenser hoop.The detached pc400 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new pc400.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6478489
• Report Number: 3005168196-2017-00580
• Device Sequence Number: 16226437
• Product Code: HCG
• UDI-Device Identifier: 00814548011417
• UDI-Public: 00814548011417
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/14/2017

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: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 4006U0305
• Device Lot Number: F31681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Initial Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1