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

Model Number	400SMTSFT0820
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the first returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock and the reported complaint was confirmed.The probable cause of the failure was likely due to resistance encountered during advancement.Forceful advancement against resistance likely contributed to the kink and fracture observed near the pusher assembly mid-joint.Further evaluation revealed that the embolization coil was detached from the pusher assembly inside the introducer sheath.This damage was incidental to the reported complaint and likely occurred due to the pusher assembly fracture.Evaluation of the second returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock and the reported complaint was confirmed.The probable cause of the failure was likely due to resistance encountered during advancement.Forceful advancement against resistance likely contributed to the kink observed near the pusher assembly mid-joint.During functional testing, resistance was encountered while attempting to advance the pusher assembly mid-joint through the introducer sheath friction lock, and the pusher assembly could not be advanced at all.Penumbra products are visually inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2021-02326.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior inferior cerebellar artery using penumbra smart coils (smart coils).During the procedure, the smart coils would not advance from the starting positions of the introducer sheaths.Therefore, the smart coils were removed.The procedure was completed using non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Correction: please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 1.Section g.Box 4.Date received by manufacturer additional information: please note that the following code was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: 1.Section h.Box 6.Result code 5: 3243 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12661627
• Report Number: 3005168196-2021-02325
• Device Sequence Number: 4212150
• Product Code: HCG
• UDI-Device Identifier: 00814548014753
• UDI-Public: 00814548014753
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022
• 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: 06/16/2025
• Device Model Number: 400SMTSFT0820
• Device Catalogue Number: 400SMTSFT0820
• Device Lot Number: F98405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• 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: 09/21/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005