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

Catalog Number CATRXKIT

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the peroneal artery using an indigo system catrx aspiration catheter (catrx), an indigo system aspiration catheter 6 (cat6), a guidewire and a sheath.During the procedure, the physician completed three passes using the catrx and removed the clot.Subsequently, during the fourth pass the physician noticed the mid section of the catrx was twisted and snapped into two pieces.The damage of the catrx was noticed outside the patient and was not used in the remainder of the procedure.Next the physician opened a new cat6.During the initial introduction, the physician kinked the cat6 at the tip.Therefore, the cat6 was removed.The procedure was stopped at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation of the returned catrx confirmed that the catheter was fractured.Evaluation revealed a kinked at the fractured location.This damage is likely the reported twist.If the catrx is retracted at an angle, damage such as a kink and subsequent fracture may occur.Further evaluation revealed bends throughout the length of the catheter.This damage was incidental to the reported complaint and likely occurred during packaging for return to penumbra.Penumbra devices 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: 16304637
• MDR Text Key: 308917278
• Report Number: 3005168196-2023-00065
• 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: 01/01/2005,03/25/2023

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: F00000441
• 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: 01/10/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• 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: 50 YR