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

Model Number	400SMTXSFT0206
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 carotid terminus using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a non-penumbra embolization device.During the procedure, after successfully implanting a non-penumbra coil in the aneurysm, the physician advanced the smart coil into the aneurysm using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then attempted to manually detach the smart coil, but the coil still failed to detach.The physician decided to remove the smart coil and microcatheter altogether.Upon retraction, the smart coil unintentionally detached in the parent vessel.Therefore, the physician removed the detached smart coil using a snare device.The procedure was completed at this point.There is no reported adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was detached.Evaluation revealed that the pusher assembly was kinked and fractured at its proximal end, and the pull wire was fully retracted.This damage likely occurred due to the manual detachment attempts during the procedure, and likely contributed to the reported embolization coil detachment upon retraction.Due to the returned condition, the root cause of the reported complaint could not be determined.Further evaluation of the device revealed that the pusher assembly had additional damage throughout its length.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.Further evaluation also revealed offset coil winds on the embolization coil.This damage likely occurred due to snaring the coil to remove from the patient vessel.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported initial detachment issue on the smart coil.

• 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: 13793462
• Report Number: 3005168196-2022-00126
• Device Sequence Number: 3905599
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022
• 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: 09/22/2026
• Device Model Number: 400SMTXSFT0206
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F109358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/18/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• 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: Female
• Date Report Sent to FDA: 01/01/2005