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	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the anterior tibial artery (at) using an indigo system aspiration catheter 7 (cat7), an indigo system lightning bolt aspiration tubing (lightning bolt aspiration tubing), an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a guidewire.During the procedure, the physician removed thrombus in the popliteal and superficial femoral artery (sfa) using the cat7 and the lightning bolt aspiration tubing.It was noted that there was still thrombus in the distal at vessel and the decision was made to use a catrx.The physician advanced a guidewire into the distal tibial vessel and inserted the catrx using the peel away introducer over the guidewire and into the sheath via ipsilateral access.Next, the physician made one pass down the distal at using the catrx and decided to remove the catrx to be flushed.While removing the catrx under aspiration, the hospital technologist experienced resistance pulling back on the catrx after the rapid exchange port of the catrx was outside of the sheath.The hospital technologist continued to pull back on the catrx and upon removing the majority of the catrx out from the sheath, the catrx had fractured at the distal end.It was reported that the entire catrx was removed and no part of the catrx was left in the vessel.The procedure was completed using a new catrx, the same sheath, and the same guidewire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned indigo system catrx aspiration catheter (catrx) confirmed a fracture on its distal shaft and revealed stretching at the fractured location.If the device is retracted against resistance during use, damage such as stretching and subsequent fracture may occur.Based on the reported complaint, the root cause of the resistance during the procedure could not be determined.Further evaluation of the device revealed an additional fracture, kinks and ovalizations on the catheter shaft, and the guidewire lumen was damaged.This damage is incidental to the complaint and the root cause could not be determined.The middle fracture segment was not returned for evaluation.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.

• 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: 21931412
• Report Number: 3005168196-2025-00145
• Device Sequence Number: 12924435
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: F00014062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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: 83 YR
• Patient Sex: Male