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

Model Number	400SMTSFT0203
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the embolization coil was detached from its pusher assembly, and therefore, the reported detachment issue could not be confirmed.Further evaluation revealed that the proximal end of the pusher assembly was fractured off, the pet lock was missing, and the pusher assembly had multiple kinks throughout its length.This damage was incidental to the reported complaint.The fractured pusher assembly and missing pet lock likely occurred due to the manual detachment during the procedure.The observed pusher assembly kinks may have occurred during handling of the device during the procedure or packaging of the device for return.Evaluation of the returned handle revealed a functional device, and the complaint could not be confirmed.During the functional test, the handle was tested on a handle fixture and passed within specification.The handle was then used to detach a demonstration smart coil without an issue.Penumbra products are visually inspected during in-process inspection and 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 to treat an arteriovenous malformation (avm) using a penumbra smart coil (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced the smart coil to the target vessel and attempted to detach it using the handle; however, the smart coil failed to detach after multiple attempts.Therefore, the physician manually detached the smart coil using a grasper.The procedure was completed at this point.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: 12737790
• Report Number: 3005168196-2021-02443
• Device Sequence Number: 4126771
• Product Code: HCG
• UDI-Device Identifier: 00814548015118
• UDI-Public: 00814548015118
• 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
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021
• 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: 05/31/2026
• Device Model Number: 400SMTSFT0203
• Device Catalogue Number: 400SMTSFT0203
• Device Lot Number: F106743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• 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: 10/08/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005