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

Catalog Number	400SMTHXSFT0102
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the distal a2 segment of the anterior cerebral artery (aca) using penumbra smart coils (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a smart coil as the first coil to the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach.Subsequently, the physician manually detached the smart coil using hemostats after multiple attempts.Then, the physician advanced another smart coil to the target vessel and attempted to detach it using the handle; however, the same issue occurred.Subsequently, the physician also manually detached the smart coil using hemostats after multiple attempts.It was also reported that the smart coil almost came out of the aneurysm after detachment after pulling on the pusher assembly of the coil to manually detach it; however, the physician was able to carefully place the smart coil back into the aneurysm by pushing it into the aneurysm using the microcatheter.The procedure was completed using other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 15415640
• Report Number: 3005168196-2022-00429
• Device Sequence Number: 2544820
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 814548015613
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2022
• 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 Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F110791
• Was Device Available for Evaluation?: No
• 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: 08/18/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• 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 Age: 28 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005