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

Catalog Number CATRXKIT

Device Problems Fracture (1260); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

Evaluation of the returned catrx confirmed a fracture.Further evaluation revealed that the catheter was kinked at the fractured location, indicating that the device likely kinked prior to fracturing.This damage typically occurs if the device is advanced against resistance.The device may become kinked and may subsequently fracture.Further evaluation also revealed kinks and ovalizations along the length of the device.This damage was incidental to the complaint and likely occurred during removal of the device from the procedure and during packaging for return to penumbra.Penumbra devices are visually 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.H3 other text : placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa), popliteal artery, and anterior tibial artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, a non-penumbra microcatheter, and a guidewire.During the procedure, the physician completed one pass using the catrx.The catrx was removed to perform an angiogram.Upon removal, the physician noticed that the catrx was fractured at the distal end.It was reported that the angiogram revealed that the distal end of the catrx migrated to the distal anterior tibial artery.The physician attempted to remove the fractured catrx distal end using a snare device; however, the catrx distal end could not be removed.The thrombectomy procedure had ended at this point.The patient was taken to another hospital and an open surgery was performed to remove the fractured distal end of the catrx.

• 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: 18636956
• MDR Text Key: 334494231
• Report Number: 3005168196-2024-00038
• Device Sequence Number: 1
• Product Code: QEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F00007857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• 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: 01/08/2024
• Initial Date FDA Received: 02/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female