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

Model Number	4002C1145
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the vertebral artery to retreat an aneurysm using penumbra coils 400 (pc400s) and a px slim delivery microcatheter (px slim).It was reported that in a prior treatment, penumbra smart coils (smart coils) and non-penumbra coils were placed in the patient's target vessel.During the procedure, while advancing the pc400 through the px slim in the vessel, the physician experienced slight resistance but was able to advance it further.The pc400 then came out of the px slim and unintentionally detached in the vessel; subsequently, the physician pushed the pc400 into the aneurysm and placed it.The procedure was completed using another pc400 and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 110.0 cm from the proximal end.The pusher assembly was fractured on its distal tip and the distal detachment tip (ddt) was not returned for evaluation.Conclusions: evaluation of the returned pc400 revealed a ddt was fractured off the distal tip of the pusher assembly.If the device is forcefully retracted against resistance, damage such as this may occur.If the pusher assembly ddt fractures, the embolization coil will become detached from the pusher assembly.The pc400 embolization coil and the px slim identified in the complaint was not returned for evaluation; therefore, the root cause of resistance experienced during the procedure could not be determined.Further evaluation revealed a pusher assembly kink.This kink was likely incidental to the reported complaint.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9674241
• Report Number: 3005168196-2020-00134
• Device Sequence Number: 380258
• Product Code: HCG
• UDI-Device Identifier: 00814548010625
• UDI-Public: 00814548010625
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 01/14/2020
• Report Date (Section F): 01/01/2005

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: 06/10/2021
• Device Model Number: 4002C1145
• Device Catalogue Number: 4002C1145
• Device Lot Number: C03416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005