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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the tibial artery using an indigo system lightning bolt aspiration tubing (lightning bolt), an indigo system aspiration catheter 6x (cat6x) and an indigo system separator 4 (sep4).It was reported that the patient had a previously implanted stent in the popliteal artery and the thrombus was located distal to the stent.During the procedure, the physician completed one pass with the cat6x then performed an angiogram.The angiogram revealed additional thrombus farther down the tibial artery.The physician attempted to complete additional passes with the cat6x, however, no thrombus was ingested.While retracting the cat6x, the physician met resistance and the cat6x became stuck.After using significant force, the cat6x was retracted and removed from the patient.The physician completed a second angiogram and decided to switch to an open embolectomy.During the open embolectomy, the physician found a fractured segment of the cat6x within the vessel.Therefore, the segment of cat6x was removed from the patient with a balloon catheter.The procedure was completed with the same balloon catheter.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 aspiration catheter 6x (cat6x) confirmed a fracture on the distal end and revealed stretching at the fractured location.If the cat6x is retracted against resistance, damage such as stretching and a subsequent fracture may occur.Based on the reported complaint, the previously placed stent within the anatomy may have contributed to some resistance.The additional force used during retraction of the cat6x after it became stuck, likely worsened the damage to a fracture.Further evaluation of the returned cat6x revealed bends and kinks along its length.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.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 84502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502
• MDR Report Key: 22884547
• Report Number: 3005168196-2025-00270
• Device Sequence Number: 13163004
• Product Code: QEW
• UDI-Device Identifier: 00810169721186
• UDI-Public: 00810169721186
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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: LITNGBT6XTX
• Device Lot Number: F00015469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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: 68 YR
• Patient Sex: Female