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

Model Number 400SMTSFT0515

Device Problem Break (1069)

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

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned smart coil pusher assembly confirmed a fracture.Evaluation revealed that the distal detachment tip (ddt) was fractured off the distal end of the pusher assembly.If the smart coil is forcefully retracted against resistance, damage such as this may occur.Further evaluation revealed that the entire clear section of the braided shaft was delaminated on the pusher assembly.The root cause of this damage could not be determined; however, the cause of this damage may have also contributed to ddt fracturing from the pusher assembly.Further evaluation also revealed that the pusher assembly was returned coiled around itself and had kinks.This damage was incidental to the reported complaint.Evaluation of the non-penumbra microcatheter revealed a fracture.If the device is manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as a kink and subsequent fracture may occur.If the device was damaged during the procedure, it may have contributed to resistance during manipulation of the smart coil within the microcatheter.The rhv returned with the non-penumbra microcatheter was undamaged.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 internal carotid artery (ica) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It should be noted that the patent's anatomy was tortuous.During the procedure, the physician successfully implanted one non-penumbra coil and one smart coil in the target vessel.While advancing the next non-penumbra coil through the microcatheter, the coil became stuck and the physician noticed that a piece of the smart coil pusher assembly had broken off inside the microcatheter.Therefore, the microcatheter containing the broken part of the pusher assembly was removed.The procedure was completed using two additional smart coils, two other coils, and a new microcatheter.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: 12981005
• MDR Text Key: 287201293
• Report Number: 3005168196-2021-02778
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014944
• UDI-Public: 00814548014944
• 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,Followup
• Report Date: 01/01/2005,04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2023
• Device Model Number: 400SMTSFT0515
• Device Catalogue Number: 400SMTSFT0515
• Device Lot Number: F82923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• 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
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2018
• 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