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

Catalog Number	CATRXKIT
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned indigo system catrx aspiration catheter (catrx) confirmed the device was fractured at the distal end and revealed stretching at the fracture.Evaluation also revealed that the guidewire lumen was damaged.If the catrx is retracted against resistance during use, damage such as stretching and a subsequent fracture may occur.It was reported that the guidewire was wrapped around the catrx prior to the device becoming fractured and the non-penumbra sheath used during the procedure was kinked.The root cause of this could not be determined; however, this likely contributed to resistance and damage to the guidewire lumen.Further evaluation revealed an additional fracture and kinks on the distal fractured segment.This damage is likely incidental to the reported complaint and may have occurred during removal of the device from the procedure.Penumbra devices 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 or Problem Description
The patient was undergoing a thrombectomy procedure in the popliteal artery using an indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath.It was reported the sheath was already in place prior to the start of the procedure.During the procedure, the physician made one pass in the target location using the catrx.After the pass, the physician was attempting to remove the catrx out from the sheath, but experienced resistance and noticed the sheath had kinked.It was also reported that the guidewire was wrapped around the catrx and the catrx became stuck inside the sheath.While pulling back on the catrx, the physician noticed the distal end of the catrx had fractured in the patient.Therefore, the physician removed the proximal end of the fractured catrx and sheath.The physician inserted a new non-penumbra sheath and used the indigo system lightning aspiration tubing (lightning) and an indigo system aspiration catheter 7 (cat7) to remove the distal fractured portion of the catrx from the patient.The entire fractured catrx was removed and no part of the catrx was left in the patient.The procedure had ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CATRX ASPIRATION CATHETER
• Common Device Name: QEX, QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22596322
• Report Number: 3005168196-2025-00245
• Device Sequence Number: 4082594
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K220683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F00015186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male