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 Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the anterior tibial artery using an indigo system catrx aspiration catheter (catrx), indigo system aspiration catheter 7 (cat7), a non-penumbra sheath, and a guidewire.During the procedure, the physician used a cat7 and sheath to successfully clear off as much thrombus from the aneurysm section of a bypass that the patient had on the leg from previous popliteal entrapment syndrome.The physician then removed the cat7 and advanced the catrx using the sheath to the anterior tibial and completed two passes.Since the target vessel was heavily thrombosed, the physician decided to remove the catrx as access to the target vessel was challenging.While retracting the catrx, the physician experienced resistance at the distal end of the sheath and noticed that the catrx was stuck in the patient''s thigh.The physician then pulled the catrx back harder and observed under fluoroscopy that the radio marker of the catrx was still visible on the screen and not moving as the rest of the catrx was being removed.It was reported that the rapid exchange lumen of the catrx had fractured.The physician used a snare device to successfully remove the fractured segment of the catrx.The procedure ended at this point since vessel access was challenging.

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 anterior tibial artery using an indigo system catrx aspiration catheter (catrx), indigo system aspiration catheter 7 (cat7), a non-penumbra sheath, and a guidewire.During the procedure, the physician used a cat7 and sheath to successfully clear off as much thrombus from the aneurysm section of a bypass that the patient had on the leg from previous popliteal entrapment syndrome.The physician then removed the cat7 and advanced the catrx using the sheath to the anterior tibial and completed two passes.Since the target vessel was heavily thrombosed, the physician decided to remove the catrx as access to the target vessel was challenging.While retracting the catrx, the physician experienced resistance at the distal end of the sheath and noticed that the catrx was stuck in the patient''s thigh.The physician then pulled the catrx back harder and observed under fluoroscopy that the radio marker of the catrx was still visible on the screen and not moving as the rest of the catrx was being removed.It was reported that the catrx fractured at the rapid exchange lumen.The physician used a snare device to successfully remove the fractured segment of the catrx.The procedure ended at this point since vessel access was challenging.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2024-00112.1.Section b.Box 1.Adverse event and/or product problem 2.Section b.Box 5.Describe event or problem 3.Section h.Box 1.Type of reportable event 4.Section h.Box 6.Patient code 1.Evaluation of the returned catrx confirmed that the catheter was fractured.Evaluation revealed a kink and stretching near the fractured location.If the catrx was advanced against resistance, damage such as a kink may occur.If the proximal end of the guidewire lumen is advanced beyond the distal tip of the non-penumbra sheath, the guidewire may buckle and resistance may be experienced upon retraction.Forceful retraction against this resistance may result in stretching and a subsequent fracture.Further evaluation revealed additional kinks along the catheter shaft.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return.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: 18985782
• MDR Text Key: 338693313
• Report Number: 3005168196-2024-00112
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00815948025448
• UDI-Public: 815948025448
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K220683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CATRXKIT
• Device Lot Number: C00012951
• 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: 02/26/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2023
• 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 Outcome(s): Required Intervention