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 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 anterior tibial artery and posterior tibial artery using an indigo system catrx aspiration catheter (catrx), indigo system separator 4 (sep4), and a non-penumbra sheath, non-penumbra microcatheter, and guidewire.During the procedure, the physician advanced the catrx over a guidewire into the distal anterior tibial artery and made the two passes using the catrx and sep4 to successfully remove the thrombus.Next, the physician advanced the same catrx with assistance of a microcatheter over the same guidewire into the patient¿s ankle.The physician then made one pass using the catrx and sep4.Subsequently, after making a second pass, the physician removed the catrx out from the sheath and noticed the distal end of the catrx had broken off and the catrx guidewire lumen was detached from the catheter.It was reported that the distal end of the catrx had broken in the patient¿s ankle under fluoroscopy.Therefore, the physician used a snare device to remove the broken catrx out from the patient.The procedure was completed using angioplasty and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(6).Please note that the following sections are being updated based on additional information provided by a penumbra sales representative: 1.Section e.Box 4.Initial reporter also sent report to fda 2.Section g.Box 3.Report source.

• 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: 15906710
• MDR Text Key: 308017127
• Report Number: 3005168196-2022-00561
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/09/2023

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: F00002074
• Was Device Available for Evaluation?: No
• 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: 11/08/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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: 76 YR
• Patient Sex: Female