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

Catalog Number CATRXKIT

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/14/2024

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the posterior tibial artery (pta) using an indigo system cat rx aspiration catheter (catrx), a non-penumbra sheath.During the procedure, the physician completed two passes using the catrx.While removing the catrx, the physician noticed that the catrx appeared to be fractured at the midshaft within the sheath under fluoroscopy.The physician pulled out the catrx from the sheath and the fractured portion of the catrx remained in the vessel.The physician attempted to remove the fractured portion of the catrx using a snare device; however, the catrx fractured end could not be removed.The procedure had ended at this point.An open surgery was performed to remove the fractured part of the catrx.The physician intended to perform an open surgery (endarterectomy procedure) regardless of the outcome of the thrombectomy.

Manufacturer Narrative

Evaluation of the returned catrx confirmed that the catheter was fractured.Evaluation revealed that the catrx was kinked at the fractured location.This indicates that the catrx likely kinked prior to fracturing.If the catrx is manipulated within a short sheath such that the guidewire lumen is extended past the sheath tip, additional resistance and damage to the catheter will likely occur.This may have contributed to the damage observed on the returned device.The reported tortuous anatomy may have also contributed to resistance experienced during the procedure.Further evaluation of the device revealed ovalization on the distal fractured segment and kinks throughout the length of the device.This damage was incidental to the complaint.The ovalization and kinks on the distal fractured segment likely occurred during removal of the device from the patient¿s body.The kinks on the proximal fractured segment occurred during packaging for device return.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.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: 18682374
• MDR Text Key: 335074501
• Report Number: 3005168196-2024-00047
• 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: 01/01/2005,02/09/2024

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: F00006171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• 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: 01/15/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• 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: 89 YR
• Patient Sex: Female