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

Catalog Number CATRXKIT

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

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the coronary artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra guide catheter, and a guidewire.During the procedure, the physician advanced a catrx over the guidewire to the target location and completed two passes.While retracting the catrx, the physician met resistance.Subsequently the catrx was kinked and fractured while exiting the rhv.The distal portion of the catrx was then removed.It was reported that the catrx was also kinked at the proximal location.The procedure was completed with a balloon and stent.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned catrx confirmed a fracture on its proximal shaft and revealed a kink at the fractured location.This damage typically occurs if the catrx is retracted against resistance at an angle.It was reported that the catrx was kinked and fractured while exiting the rhv.If the rhv is not fully opened during retraction, resistance may encounter and if the catrx is retracted against this resistance at an angle, damage such as a kink and subsequent fracture may occur.Further evaluation of the device revealed an ovalization distal to the fractured location, additional kinks and bends along the length of the catheter shaft, and a kink on the proximal end of the guidewire lumen.This damage was incidental to the complaint.The ovalization likely occurred during removal of the distal fractured segment from patient¿s body.The kinks and bends on the catheter shaft and a kink on the guidewire lumen may have occurred during packaging of the device for return to penumbra.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.

• 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: 19100665
• MDR Text Key: 340804034
• Report Number: 3005168196-2024-00139
• 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,Followup
• Report Date: 01/01/2005,04/26/2024

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 Catalogue Number: CATRXKIT
• Device Lot Number: F00010086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• 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: 03/22/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2024
• 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: 57 YR
• Patient Sex: Male