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

Catalog Number CATRXKIT

Device Problems Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/07/2024

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the anterior tibial artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a glidewire.During the procedure, a glidewire was advanced down the anterior tibial artery and past a lesion.The physician then advanced a catrx to the target location and completed one pass in the posterior tibial artery.While attempting to make the next pass, the physician experienced resistance while advancing the catrx past the lesion in the anterior tibial artery.It was noted that the physician used excessive force to advance the catrx; subsequently, the catrx buckled near the midshaft and the distal end.Therefore, the physician decided to remove the catrx from the patient.After removal, the distal end of the catrx was noticed to be fractured inside the patient and a portion of the glidewire was also noticed to be wrapped around the catrx near the fracture.The physician used a snare device to retract the fractured catrx into the sheath to where the sheath entered the patient.The physician then performed a surgical cut down to remove the fractured catrx.The procedure ended at this point.

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• 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: 18632860
• MDR Text Key: 334448817
• Report Number: 3005168196-2024-00036
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 814548017556
• 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: F00006940
• Was Device Available for Evaluation?: No
• 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: 01/07/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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: 68 YR
• Patient Sex: Male