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

Model Number	400SMTXSFT0103
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	08/20/2020
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 anterior communicating artery (acom) using penumbra smart coils (smart coils), non-penumbra coils, a benchmark 6f 071 delivery catheter (benchmark), and a non-penumbra microcatheter.During the procedure, two other coils were successfully implanted in the target location.While attempting to advance a smart coil past the hub of the microcatheter, the physician reported that it felt tight while pushing the coil a few millimeters through the hub.It was also reported that the smart coil became stuck and did not advance past the hub.Therefore, the smart coil was removed.The procedure was completed using one other coil, the same microcatheter, and the same benchmark.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 its pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not aligned properly within the hub of a parent microcatheter, resistance may be experienced and damage such as offset coil winds may occur.During the functional test, resistance was encountered while attempting to advance the smart coil pusher assembly out of its introducer sheath due to offset coil winds on the proximal end of the embolization coil, and the smart coil could not be advanced any further.The smart coil pusher assembly was retracted out of its introducer sheath and re-sheathed, and resistance was again encountered due to the offset coil winds, and the smart coil could not be advanced any further.The offset coil winds likely prevented the smart coil from being advanced past the hub of the microcatheter during the procedure.Penumbra coils are visually 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 SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10520890
• Report Number: 3005168196-2020-01437
• Device Sequence Number: 19726699
• Product Code: HCG
• UDI-Device Identifier: 00814548015194
• UDI-Public: 00814548015194
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 08/20/2020
• 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: 01/15/2025
• Device Model Number: 400SMTXSFT0103
• Device Catalogue Number: 400SMTXSFT0103
• Device Lot Number: F95639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005