MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6X; QEW

Catalog Number	LITNGBT6XTX
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left femoral popliteal vein graft using an indigo system aspiration catheter 6x (cat6x), an indigo system lightning bolt aspiration tubing (lightning bolt), and a non-penumbra sheath (6f).During the procedure, the physician made one pass in the target location using the cat6x.While advancing the cat6x to the distal portion of the vein graft for a second pass, the physician experienced resistance and the cat6x became stuck.The sheath had prolapsed into the aorta and the distal end of the cat6x fractured.The physician attempted to remove the fractured portion of the cat6x using a loop snare device (7mm), but the attempt was unsuccessful.The fractured portion of the cat6x was left in the femoral artery to the popliteal artery vein graft in the left leg.An infusion catheter was placed in the vessel to administer tissue plasminogen activator (tpa) overnight with no changes to the baseline status.The following day, the physician performed another endovascular procedure to remove the fractured distal end of the cat6x using a snare device, but the attempt was unsuccessful.The physician performed an open surgery and was able to successfully remove the fracture portion of the cat6x.It was reported that the patient is doing fine.
Additional Manufacturer Narrative
Evaluation of the returned indigo system aspiration catheter 6x (cat6x) confirmed a fracture on the distal length and revealed stretching at the fractured location.If the cat6x is manipulated against resistance, damage such as stretching and a subsequent fracture may occur.The root cause of resistance during the procedure could not be determined.Further evaluation of the device revealed multiple kinks on the catheter shaft.The kinks along the distal length likely occurred during advancement against resistance and some kinks are likely 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 ASPIRATION CATHETER 6X
• Common Device Name: 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: 22976879
• Report Number: 3005168196-2025-00289
• Device Sequence Number: 9549139
• Product Code: QEW
• UDI-Device Identifier: 00810169721186
• UDI-Public: 00810169721186
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K242319
• 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): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LITNGBT6XTX
• Device Lot Number: F00016580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male