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

Model Number	400SMTSTD1360
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the device was returned without its introducer sheath; therefore, the reported smart coil would not advance from its initial position during the procedure was unable to be confirmed.Further evaluation of the device revealed that the pet lock was separated, the pusher assembly was kinked, the embolization coil was detached from the pusher assembly and had offset coil winds.Based on the reported complaint, this damage was likely incidental.The root cause of the damage could not be determined.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement.Forceful advancement against this resistance may have contributed to the kink near the pusher assembly mid-joint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then the smart coil was able to advance through its introducer sheath without an issue.Further evaluation of the device revealed an additional pusher assembly kink.This damage was likely incidental to the complaint.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement.Forceful advancement against this resistance may have contributed to the kinks near the pusher assembly mid-joint.During functional testing, the smart coil was unable to be advanced from its returned position due to the kinks in the pusher assembly.Further evaluation of the device revealed an additional pusher assembly kink.This damage was likely incidental to the complaint.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.The investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.This report is associated with mfr report numbers: 3005168196-2021-01698 and 3005168196-2021-01699.
Event or Problem Description
The patient was undergoing a coil embolization in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, three smart coils would not advance from the starting position of their introducer sheaths due to the friction locks being too tight.The procedure was completed using a new smart coil.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: 12252786
• Report Number: 3005168196-2021-01697
• Device Sequence Number: 20048899
• Product Code: HCG
• UDI-Device Identifier: 00814548014265
• UDI-Public: 00814548014265
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 07/30/2021
• 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: 03/09/2022
• Device Model Number: 400SMTSTD1360
• Device Catalogue Number: 400SMTSTD1360
• Device Lot Number: C01448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• 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: 07/06/2021
• Initial Report FDA Received Date: 07/30/2021
• 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