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

Model Number	400SMTSTD0620
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was intact with the pusher assembly.Further evaluation revealed that the pet lock was separated, the pull tube was retracted completely out of the pusher assembly proximal end, and the pull wire was in its initial position within the pusher assembly ddt.This indicates that the pull tube likely fractured from the pull wire within the pusher assembly.The root cause of this damage could not be determined; however, this damage likely contributed to inability to detach the embolization coil during the procedure.Further evaluation revealed offset coil winds and pusher assembly kinks on the proximal end.The pusher assembly kink was likely a result of the manual detachment attempt.The offset coil winds were likely incidental to the reported complaint.Penumbra coils are 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician used the handle to successfully implant three smart coils in the target location.While attempting to detach the next smart coil, the handle did not detach it after more than three attempts were made to do so.The physician attempted to manually detach the smart coil without success.Therefore, the smart coil was removed from the patient.The procedure was completed using an additional smart coil, the same handle, and the same microcatheter.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: 11658178
• Report Number: 3005168196-2021-00737
• Device Sequence Number: 3538094
• Product Code: HCG
• UDI-Device Identifier: 00814548014678
• UDI-Public: 00814548014678
• Combination Product (Y/N): Y
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2021
• 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: 04/12/2025
• Device Model Number: 400SMTSTD0620
• Device Catalogue Number: 400SMTSTD0620
• Device Lot Number: F97272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• 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: 03/16/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005