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

Catalog Number	400SMTHXSFT0410
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the returned pusher assemblies had bends along their length.Each of the three embolization coils had offset coil winds and were snaking within their introducer sheath on the proximal end.None of the embolization coils were able to be advanced out of their introducer sheaths.Conclusions: evaluation of the returned smart coils revealed the embolization coils had offset coil winds concentrated on the proximal end of each coil.If the introducer sheath is not properly aligned in the hub of the microcatheter prior to advancement, resistance may be experienced.Subsequently advancing the device against this resistance will likely cause the embolization coil to become kinked.Further evaluation revealed kinks on the length of each pusher assembly.This damage was likely incidental and may have occurred during packaging for return to penumbra.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.This report is associated with mfr report numbers: 3005168196-2018-02020; 3005168196-2018-02021.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils).During the procedure, three smart coils would not advance into a non-penumbra microcatheter; therefore, they were removed.It was reported that the coils seemed to get stuck in the hub of the microcatheter.The procedure was completed using other coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7963202
• Report Number: 3005168196-2018-02022
• Device Sequence Number: 13824940
• Product Code: HCG
• UDI-Device Identifier: 00814548015835
• UDI-Public: 00814548015835
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• 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): 09/13/2018
• 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: 04/16/2022
• Device Catalogue Number: 400SMTHXSFT0410
• Device Lot Number: F75688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005