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

Catalog Number CATRXKIT

Device Problem Break (1069)

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

Event Date 11/23/2022

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 femoral artery, popliteal artery and anterior tibial artery using an indigo system catrx aspiration catheter (catrx), an indigo system aspiration catheter 7 (cat7), a non-penumbra guide sheath and a guidewire.During the procedure, after removing the clot from the target vessels using the cat7, the cat7 was removed.The physician then advanced the catrx through the sheath to get further down the target vessel.While advancing the catrx, the physician kinked the catrx and subsequently, the catrx broke in half.Therefore, the physician used a balloon through the catrx and removed the remaining piece of the catrx from the patient.The procedure was complete using a cat6 and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Catrx was advanced through a short sheath.If the catrx is advanced such that the entire guidewire lumen is distal to the guide catheter, additional resistance and difficulty tracking may be experienced.This likely contributed to the catrx becoming kinked within patient anatomy.Subsequent manipulation and retraction of the kinked device against resistance likely contributed to the catrx becoming fractured.Evaluation revealed an additional fracture and kink on the catheter shaft.This damage was likely incidental to the reported complaint.This damage may have occurred post-procedure or during packaging 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 CAT RX 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: 15974528
• MDR Text Key: 308198923
• Report Number: 3005168196-2022-00576
• 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: K163618
• 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: 01/01/2005,01/12/2023

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: F113878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• 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: 11/23/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/17/2022
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2022
• 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: 69 YR
• Patient Sex: Male