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 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the tibial artery using an indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath.It was reported the physician placed the patient on lysis (thrombolytic) for over two days.During the procedure, the physician performed an angiography and noticed the anterior tibial (at) was occluded.The physician advanced the catrx down the tibial artery with resistance and made two passes using the catrx.A follow up angiography revealed some residual clot, and the vessel was determined to be calcified.The physician then advanced the catrx with resistance and made two additional passes in the vessel using the catrx.However, after the fourth pass, the catrx fractured.It was reported that the catrx fractured outside of the patient and inside the sheath.Therefore, the physician removed the sheath and catrx together as a unit.The procedure ended at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned catrx confirmed that the catheter was fractured.If the catrx is advanced against resistance during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed additional kinks along the length of the catheter shaft, stretching along the distal fracture segment, and the guidewire lumen was damaged.This damage was incidental to the reported complaint and the root cause could not be determined.The damage guidewire lumen may have contributed to resistance during the procedure.The stretching likely occurred during retraction against resistance.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: 18069974
• MDR Text Key: 328145385
• Report Number: 3005168196-2023-00493
• 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: 01/01/2005,12/21/2023

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: F00006470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/09/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• 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 Age: 70 YR
• Patient Sex: Male