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	06/10/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the tibial artery using an indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath.It was noted that the bifurcation was not steep, and the sheath was up and over onto the contralateral side.It was reported that a stent was placed in the superficial femoral artery (sfa) prior to the use of catrx.The physician decided to use the catrx to remove the thrombus distal to the stent in the tibial artery.During the procedure, the catrx was advanced to the target location, and one pass was completed.While removing the catrx, the catrx fractured mid-shaft.The proximal portion of the catrx was removed.The physician attempted to remove the distal portion of the catrx using a snare device, however, the attempt was not successful.A balloon catheter was used to remove the distal segment of the catrx.The procedure was considered completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up mfr report: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned indigo system catrx aspiration catheter (catrx) confirmed that the catheter was fractured.Evaluation revealed that the device was kinked at the fractured location, indicating that the catrx likely kinked prior to fracturing.If the catrx is manipulated against resistance during use, damage such as a kink and subsequent fracture may occur.Based on the reported event, the resistance was likely due to already placed stent.Further evaluation of the catrx revealed a kink on the proximal fractured segment, bends throughout the catheter and a kink and ovalization on the distal fractured segment.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the tibial artery using an indigo system catrx aspiration catheter (catrx) and a non-penumbra sheath.It was noted that the bifurcation was not steep, and the sheath was up and over onto the contralateral side.It was reported that a stent was placed in the superficial femoral artery (sfa) prior to the use of catrx.The physician decided to use the catrx to remove the thrombus distal to the stent in the tibial artery.During the procedure, the catrx was advanced to the target location, and one pass was completed.While removing the catrx, the catrx fractured mid-shaft.The proximal portion of the catrx was removed.The physician attempted to remove the distal portion of the catrx using a snare device, however, the attempt was not successful.A balloon catheter was used to remove the distal segment of the catrx.The procedure was considered completed.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: 22398445
• Report Number: 3005168196-2025-00228
• Device Sequence Number: 11961875
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 07/25/2025

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: F00015350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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: 83 YR
• Patient Sex: Male