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

Catalog Number	400SMTHXSFT0510
Medical Device Problem Codes	Difficult or Delayed Separation (4044); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
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 to treat a basilar tip aneurysm using a penumbra smart coil (smart coil), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully detached two smart coils in the target vessel using the handle.Next, the physician advanced another smart coil to the target vessel using the microcatheter and attempted to detach it using the handle; however, the coil failed to detach.While retracting the smart coil to remove it, the smart coil unintentionally detached in the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed, and the coil was flushed out of the microcatheter.The procedure was completed using non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
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:3005168196-2022-00321 1.Section h.Box 6.Device code 1.Evaluation of the returned smart coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated, and the pull wire was retracted from the pusher assembly ddt.This indicated that the smart coil was detached properly.If the pull wire is retracted from the ddt, the embolization coil will detach.The root cause of the reported detachment issue could not be determined.Further evaluation of the device revealed kinks on the pusher assembly and offset coil winds on the embolization coil.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.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 detachment issue.

• 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: 14951428
• Report Number: 3005168196-2022-00321
• Device Sequence Number: 6953116
• Product Code: HCG
• UDI-Device Identifier: 00814548015859
• UDI-Public: 814548015859
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/10/2022
• 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: 08/05/2026
• Device Catalogue Number: 400SMTHXSFT0510
• Device Lot Number: F108230
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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