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

Model Number	400SMTHXSFT2H04
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
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.This report is associated with mfr report number: 3005168196-2020-00906.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the tip of the basilar artery using penumbra smart coils (smart coils).During the procedure, a smart coil would not advance at all from the starting position within its introducer sheath.Therefore, the smart coil was removed.The physician then attempted to advance another smart coil; however, the same issue occurred.The smart coil was therefore removed.The procedure was completed using a new smart coil.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assembly.The pusher assembly was kinked at approximately 129.0 cm from the proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock and the pusher assembly was kinked.If the mid-joint become retracted through the friction lock, resistance will likely be experienced while advancing the device.Forcefully advancing the device against this resistance may have contributed to the kink on the pusher assembly.During functional testing, the smart coil was unable to advance within its introducer sheath due to the mid-joint was retracted proximal to the friction lock.After proper re-sheathed the device, the smart coil was able to be advanced through its introducer sheath and a demonstration microcatheter with resistance due to the kink on the pusher assembly.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted into the introducer sheath friction lock and the pusher assembly was kinked.If the mid-joint become retracted into the friction lock, resistance will likely be experienced while advancing the device.Forcefully advancing the device against this resistance may have contributed to the kinks on the pusher assembly.During functional testing, the mid-joint was advanced through the friction lock with resistance.After the mid-joint was advanced through the friction lock, the device was able to advance through its introducer sheath and a demonstration microcatheter with resistance due to the kinks on the pusher assembly.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.This report is associated with mfr report number: 1.3005168196-2020-00906 h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10254401
• Report Number: 3005168196-2020-00905
• Device Sequence Number: 19546457
• Product Code: HCG
• UDI-Device Identifier: 00814548015750
• UDI-Public: 00814548015750
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 06/16/2020
• 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: 10/08/2023
• Device Model Number: 400SMTHXSFT2H04
• Device Catalogue Number: 400SMTHXSFT2H04
• Device Lot Number: F86346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005