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

Model Number CATRXKIT

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned catrx revealed kinks on the distal shaft, proximal to the guidewire lumen.If the device is forcefully advanced against resistance, damage such as kinks may occur.During functional testing, a demonstration guidewire was advanced through the guidewire lumen without an issue.Subsequently, the catrx with the guidewire within its lumen were advanced through a demonstration benchmark without an issue.The root cause of the inability to advance the catrx during the procedure could not be determined.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 right coronary artery (rca) using an indigo system catrx aspiration catheter (catrx), a non-penumbra guide catheter and a guidewire.During the procedure, the catrx was able to advance through the rhv but would not advance through the hub of the guide catheter.Subsequently, the catrx kinked at the proximal end.Therefore, the catrx was removed.The procedure was completed using a balloon catheter and the same guide catheter.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Type of Device: QEX, QEW
• 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: 12309890
• MDR Text Key: 266169333
• Report Number: 3005168196-2021-01795
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/11/2021

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: 10/09/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F101010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• 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
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2020
• 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 Age: 63 YR