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	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the tibial artery using an indigo system catrx aspiration catheter (catrx), a sheath, and a guidewire.During the procedure, the catrx was advanced to the target location to aspirate clot.The physician decided to retract the catrx.While retracting, resistance was experienced.The physician continued to retract and fractured the catrx at the midshaft in the target vessel.The break was identified under fluoroscopy.A vascular surgeon performed a surgical cut down to remove the fractured segment of the catrx.
Additional Manufacturer Narrative
Evaluation of the returned indigo system catrx aspiration catheter (catrx) confirmed the catheter was fractured.Evaluation revealed that the device was kinked at the fractured location, indicating the device likely kinked prior to fracturing.If the device is manipulated against resistance during use, damage such as a kink and subsequent fracture may occur.The root cause of resistance during the procedure could not be determined.Further evaluation revealed an additional fracture on the proximal end, damaged guidewire lumen and kinks.This damage is incidental to the reported complaint and the root cause could not be determined.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: 22119950
• Report Number: 3005168196-2025-00183
• Device Sequence Number: 17931456
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/30/2025

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: F00010771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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: 71 YR
• Patient Sex: Male