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

Catalog Number 400SMTHXSFT0204

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned smart coil revealed that the ddt was fractured at the distal end of the pusher assembly and the complaint was confirmed.If the pusher assembly is retracted against resistance, damage such as a ddt fracture may occur.The complaint reported that the incident occurred after the smart coil was successfully implanted.Further evaluation revealed that the pusher assembly was kinked throughout its length.This damage was 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 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, a non-penumbra catheter, and a guidewire.During the procedure, the physician successfully implanted a smart coil into the target location.After removing the smart coil pusher wire from the microcatheter, the physician noted it was stretched and broken into two pieces at the distal end.Therefore, the microcatheter was removed and flushed to remove the broken piece of the smart coil pusher wire.The procedure was continued using three smart coils, the same handle, the same microcatheter, the same catheter, and the same guidewire.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: 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: 15283245
• MDR Text Key: 305190610
• Report Number: 3005168196-2022-00388
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 814548015712
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/24/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F100071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male