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

Model Number	400SMTHXSFT0102
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the first returned smart coil pusher assembly could not confirm the reported complaint.The embolization coil was detached and not returned for evaluation.The evaluation also revealed that the pusher assembly was kinked and fractured at its proximal end, the pull wire was fractured at its proximal end, and the pull wire was retracted from the pusher assembly ddt.This damage was likely a result of the manual detachment attempted during the procedure.Based on the returned condition, the root cause of the reported coil detachment issue could not be determined.Further evaluation of the device revealed additional pusher assembly kinks.This damage was likely incidental to the complaint.Evaluation of the second returned smart coil pusher assembly could not confirm the reported complaint.The embolization coil was detached and not returned for evaluation.The evaluation also revealed that the pusher assembly and the pull wire were fractured at their proximal end, and the pull wire was retracted from the pusher assembly ddt.This damage was likely a result of the manual detachment attempted during the procedure.Based on the returned condition, the root cause of the reported coil detachment issue could not be determined.Further evaluation of the device revealed additional pusher assembly kinks.This damage was likely incidental to the complaint.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2021-02129.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (aca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and a guidewire.It should be noted that the patient's anatomy was tortuous, narrowed, and calcified.During the procedure, eight coils and two smart coils were implanted into the target location.While attempting to detach the next smart coil, the handle failed to detach the coil.It was also reported that manual detachment failed.Therefore, the smart coil was removed.While attempting to detach the next smart coil, the same issue occurred.Therefore, the smart coil was removed.The procedure was completed using another 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: 12530595
• Report Number: 3005168196-2021-02128
• Device Sequence Number: 4231505
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2021
• 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: 11/15/2025
• Device Model Number: 400SMTHXSFT0102
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F101998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• 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: 09/01/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005