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

Catalog Number	4006C0410
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2016
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 bent in multiple locations along the length of the hypotube.The distal detachment tip (ddt) was fractured off of the pusher assembly and the embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned device revealed the ddt was fractured off of the pusher assembly.This type of damage typically occurs due to forceful retraction of the pc400 coil against resistance.If the distal detachment tip becomes separated from the pusher assembly, it will likely cause the embolization coil to become detached.Since the px slim used in the procedure was not returned for evaluation, the root cause of the initial resistance experienced by the physician could not be determined.Further evaluation revealed the pusher assembly was bent in multiple locations.This damage was likely incidental and may have occurred during packaging for return.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, while attempting to deploy a pc400 coil into the aneurysm, the physician encountered resistance and decided to retract the coil to reposition it.However, while the coil was being retracted, it unintentionally detached without any "snap" or significant pulling, inside the px slim delivery microcatheter (px slim).With several centimeters of the coil already in the aneurysm, the physician then carefully pulled the px slim out of the patient and was able to pull the entire pc400 coil out with it without an issue.The procedure was stopped at this point.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: 5780219
• Report Number: 3005168196-2016-00962
• Device Sequence Number: 13499045
• Product Code: HCG
• UDI-Device Identifier: 00814548011912
• UDI-Public: 00814548011912
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/10/2016

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: 11/28/2023
• Device Catalogue Number: 4006C0410
• Device Lot Number: F66697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2016
• Initial Report FDA Received Date: 07/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR