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 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned catrx confirmed a fracture on its mid-shaft.This damage likely occurred during removal of the device as mentioned in the complaint.If the catrx is retracted at an extreme angle during use, damage such as a kink and subsequent fracture may occur.Further evaluation of the device revealed kinks throughout the length of the catheter.Based on the returned condition, this damage was incidental to the complaint and occurred during packaging for the device return.Penumbra products are visually 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.

Event Description

The patient was undergoing a thrombectomy procedure in the distal right tibial artery using an indigo system catrx aspiration catheter (catrx), indigo system separator 4 (sep4), and a non-penumbra sheath.During the procedure, the physician made the first pass using the catrx.Next, the physician made approximately three to four passes in the target location using the catrx and sep4.It was reported that an angiogram was performed through the sheath that revealed poor visualization of the vessel.The physician was finished with the aspiration part of the procedure and decided to remove the catrx and sep4 together as a unit.However, after retracting the catrx halfway out from the sheath, the distal one third of the catrx broke into two separate pieces.It was reported that the location of the break to the catrx was outside the sheath and approximately ten centimeters of the broken catrx was still inside the sheath; therefore, the physician was able to manually pull and remove the broken segment of the catrx out from the sheath.The physician decided to further treat the proximal segment of the artery using a balloon.There was no report of an adverse effect to the patient.

• 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: 15513573
• MDR Text Key: 306090408
• Report Number: 3005168196-2022-00459
• 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
• Report Date: 01/01/2005,09/29/2022

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: F00000414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• 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: 09/16/2022
• Initial Date FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• 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: Female