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

Catalog Number	4002C1040
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
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 thoracic aorta (ta) and the left subclavian artery (sca) using penumbra coil 400s (pc400s).During the procedure, the physician stented the ta and advanced a non-penumbra microcatheter into the sca.The physician then successfully placed three competitors'' coils into the sca.When attempting to advance the fourth coil, a pc400, through the microcatheter, the physician reported feeling resistance at the proximal part and it could not advance more than 5 cm past the hub.While withdrawing the pc400 in an attempt to re-advance it, the pc400 unintentionally detached within the microcatheter.The physician then removed the pc400 coil by hand and it was no longer used in the procedure.The procedure was completed using three additional pc400 coils.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 fractured at approximately 5.0 cm from the proximal end.The pull wire was pulled out of the distal detachment tip (ddt) and the embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned pc400 revealed a fractured pusher assembly and a detached embolization coil.If the pusher assembly is fractured and the two fractured segments are separated, the pull wire may be retracted out of the ddt and the embolization coil will detach from its pusher assembly.The root cause of the fractured pusher assembly could not be determined.The non-penumbra microcatheter identified in the complaint was not returned for evaluation.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.Conclusions code 1:  4316 - the investigation findings do not lead to a clear conclusion about the cause of the fractured pusher assembly.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8436490
• Report Number: 3005168196-2019-00497
• Device Sequence Number: 16657117
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019
• 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: 01/06/2026
• Device Catalogue Number: 4002C1040
• Device Lot Number: F81329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005