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

Catalog Number CATRXKIT

Device Problem Fracture (1260)

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

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned catrx confirmed that the catheter was fractured on its distal shaft.Further evaluation revealed that the guidewire lumen was damaged on its proximal end and stretching at the fractured site on the distal shaft.If the guidewire lumen is advanced distal to the tip of the non-penumbra sheath, it will allow the guidewire to prolapse.If this occurs, resistance may encounter during retraction of the catrx from the non-penumbra sheath.Retraction against this resistance would likely contribute to the guidewire lumen damage and stretching and fracture on the distal shaft of the catrx.Further evaluation revealed a proximal fracture and kinks throughout the length of the catheter and an ovalization on the catheter shaft.Based on the damage at the fractured location on the proximal shaft, the fracture on the proximal shaft was likely the result of a kink.If the catrx is advanced against resistance, damage such as a kink and subsequent fracture may occur.The kinks and ovalization were incidental to the complaint and likely occurred during removal from the patient body or 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.H3 other text : placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the distal anterior tibial artery using an indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath.During the procedure, the physician experienced resistance while advancing the catrx through the anatomy and decided to retract the catrx.However, upon retracting the catrx, the physician fractured the midshaft and distal end of the catrx.It was reported that the fractured distal end of the catrx had separated and remained in the patient¿s vessel.The physician then noticed the piece of the catrx that was in the vessel was fractured in two pieces.Therefore, the physician performed a cutdown surgery of the artery and removed the two fractured pieces of the catrx.The physician decided to do open embolectomy to complete the procedure.There was no report of an adverse effect to the patient.

• 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: 18196099
• MDR Text Key: 329570615
• Report Number: 3005168196-2023-00527
• 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
• Report Date: 01/01/2005,11/22/2023

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
• Date Returned to Manufacturer: 11/06/2023
• 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: 10/31/2023
• Initial Date FDA Received: 11/22/2023
• 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: 79 YR
• Patient Sex: Male