MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 ASPIRATION CATHETER; QEW

Catalog Number	CAT8XTORQ115KIT
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in a stent previously placed in the superficial femoral artery (sfa) using an indigo system aspiration catheter 8 (cat8), a non-penumbra sheath, and a guidewire.The physician advanced the cat8 through the stent and initiated aspiration.After four passes, while retracting the cat8, the physician experienced resistance in the mid-section of the stent.Under fluoroscopy, the markerband was observed to have become dislodged and remained within the stent.A snare was advanced through the sheath, and the detached markerband was successfully retrieved from the stent.The procedure was completed using a new cat6 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned indigo system aspiration catheter 8 (cat8) confirmed that the markerband was detached from the catheter and that the distal tip of the cat8 was damaged.Operation within the stent may have contributed to the damage to the distal tip of the cat8 and contributed to the markerband becoming detached.Further evaluation revealed kinks on the catheter shaft.This damage was incidental to the complaint and may have occurred during packaging of the device for return.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 CAT 8 ASPIRATION CATHETER
• 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 25192259
• Report Number: 3005168196-2026-00167
• Device Sequence Number: 10088371
• Product Code: QEW
• UDI-Device Identifier: 00815948022324
• UDI-Public: 00815948022324
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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 Expiration Date: 06/22/2026
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H00003087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2023
• 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: Unknown