MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT RX ASPIRATION CATHETER; QEX, QEW

Model Number CATRXKIT

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned catrx revealed that the device was fractured on its proximal shaft.This damage is likely the reported break on the distal end.Further evaluation revealed a kink proximal to the fracture.If the device is forcefully advanced against resistance, damage such as kinks may occur.Subsequently, if the device is retracted against resistance or is retracted at an extreme angle during removal from a parent catheter, damage such as a fracture may occur.The root cause of resistance during the procedure could not be determined.Further evaluation revealed the device had bends throughout its length.This damage was likely incidental to the reported complaint.Penumbra catheters 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 thrombectomy procedure in the coronary vein using an indigo system catrx aspiration catheter (catrx), guidewire, and a non-penumbra guide catheter.During the procedure, the physician completed two passes using the catrx over a guidewire.Subsequently, while advancing the catrx for a third pass, the physician experienced resistance and decided to retract the catrx.However, upon retraction, the proximal shaft of the catrx broke into two pieces but was still connected by a string.Therefore, the physician pulled and removed the catrx out from the guide catheter.The procedure was completed using a non-penumbra catheter (angiojet) and the same guide catheter.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT RX ASPIRATION CATHETER
• Type of Device: QEX, QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12740988
• MDR Text Key: 280132617
• Report Number: 3005168196-2021-02474
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): Y
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 01/01/2005,11/02/2021

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 Expiration Date: 04/28/2024
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F105837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• 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: 10/05/2021
• Initial Date FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• 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 Age: 78 YR
• Patient Weight: 91