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

Catalog Number	CATRXKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right femoral artery through the tibiofibular trunk using an indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath due to thrombus that traveled distal within the vessel toward the foot during an angioplasty.During the thrombectomy procedure, after advancing the catrx into the sheath and connecting the tubing, the catrx was noticed to be fractured at the hub.Therefore, the catrx was removed by hand.A second catrx was opened.The second catrx was advanced into the sheath and was connected to the tubing.There was no flow into the canister.The physician then noticed the catrx was fractured.The proximal portion of the catrx was removed.The physician performed open surgery to remove the fractured distal segment of the catrx.It is unknown how the procedure was completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right femoral artery through the tibiofibular trunk using an indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath after angioplasty was performed.After angioplasty, thrombus traveled distal within the vessel toward the foot.During the thrombectomy procedure, after advancing the catrx into the sheath and connecting the tubing, the catrx fractured at the hub.The catrx was removed by hand and a second catrx was opened.The second catrx was advanced into the sheath and connected to the tubing.There was no flow into the canister.The physician then noticed the catrx was fractured.The proximal portion of the catrx was removed.The fractured segment of the catrx was within the left external iliac artery.The physician was unable to remove the fractured segment after multiple snare attempts.The physician performed open surgery to remove the fractured distal segment of the catrx.It is unknown how the procedure was completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that this complaint was also submitted to the fda by the user facility.The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section b.Box 5.Describe event or problem.2.Section e.Box 4.Initial reporter also sent report to fda.3.Section g.Box 2.Report source.4.Section h.Box 6.Health effect impact codes.
Additional Manufacturer Narrative
Evaluation of the returned indigo system catrx aspiration catheter (catrx) confirmed a proximal fracture.Evaluation revealed the catrx was kinked at the fracture location.If the device is advanced against resistance, damage such as a kink may occur.Subsequent manipulation of a kinked device may lead to fracture.The fracture on the catrx likely contributed to the aspiration issue during the procedure.Further evaluation revealed kinks and an additional fracture on the catheter shaft.This damage is incidental to the reported complaint and likely occurred during snaring for removal.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: 23401359
• Report Number: 3005168196-2025-00346
• Device Sequence Number: 15997396
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2025

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: F00016467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 12/13/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/03/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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: 49 YR
• Patient Sex: Male