MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 7; QEW

Catalog Number	LITNGBT7TQ130
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
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 superficial femoral artery (sfa) to the popliteal and tibial artery using an indigo system catrx aspiration catheter (catrx), a 7f non-penumbra short sheath, an indigo system aspiration catheter 7 (cat7), an indigo system lightning bolt aspiration tubing (lightning bolt), a 10f non-penumbra sheath, and a guidewire (.014).During the procedure, while advancing the catrx to make the first pass, the catrx kept getting stuck on the guidewire.It was reported that there was possible damage to the midshaft of the catrx.Therefore, the catrx was removed.The physician then advanced a cat7 and made one pass in the target location.While advancing the cat7 down the sfa for the second pass, the physician experienced resistance and noticed the distal end of the cat7 had prolapsed and fractured in the sfa.The physician was able to pull and remove the proximal end of the cat7.The 7f sheath was removed and exchanged to a 10f sheath.A snare device was then used through the 10f sheath to remove the fractured distal segment of the cat7.The physician performed an angiogram and ended the procedure at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned indigo system aspiration catheter 7 (cat7) confirmed a distal fracture.Evaluation revealed signs of kinking and torquing at the fracture site.If the device is torqued unrestrained against resistance, damage such as a fracture may occur.The root cause of resistance during the procedure could not be determined.Further evaluation revealed bends and kinks on the cat7 segments.This damage is likely incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.The damage to the distal fractured segment may have occurred during snaring.Penumbra devices are visually 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 7
• 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: 21862269
• Report Number: 3005168196-2025-00124
• Device Sequence Number: 20007440
• Product Code: QEW
• UDI-Device Identifier: 00815948025462
• UDI-Public: 00815948025462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223186
• 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): 05/09/2025

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: LITNGBT7TQ130
• Device Lot Number: H00006051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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 Sex: Male