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

Catalog Number	LITNGBT7TQ130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned indigo system aspiration catheter7 (cat7) confirmed a fractured on its distal end.Evaluation revealed signs of torquing at the fractured location.If the cat7 is rotated unrestrained against resistance, damage such as a fracture may occur.Based on the reported event, the root cause of the resistance could not be determined.Further evaluation of the cat7 revealed kinks and bends along the length of the catheter and ovalizations along the returned fractured distal segment.This damage was incidental to the reported complaint.The ovalizations likely occurred during removal of the distal fractured segment from the patient¿s body, and kinks and bends may have occurred during packaging for return.Penumbra devices 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 brachial vein using an indigo system aspiration catheter 7 (cat7) and a non-penumbra sheath (7f).The physician performed nine passes using the cat7.After completion of the thrombectomy procedure, the physician removed the cat7 to deliver a non-penumbra stent to the target location.At this time, the physician was unaware that the cat7 fractured, leaving a fragment within the vessel.When the physician attempted to advance the stent, the vessel was found to be obstructed.It was noted that the fractured cat7 fragment was lodged in the sharp curve of the arteriovenous (av) fistula.A non-penumbra balloon device (2.5 x 40mm) was used to successfully remove the cat7 fragment.All cat7 fragments were fully retrieved from the patient.The stent was then placed in the av fistula, and the procedure was completed at this point.There was no report of an adverse effect to the patient.

• 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 25299844
• Report Number: 3005168196-2026-00176
• Device Sequence Number: 9315027
• Product Code: QEW
• UDI-Device Identifier: 00815948025462
• UDI-Public: 00815948025462
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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 Catalogue Number: LITNGBT7TQ130
• Device Lot Number: H00010299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2026
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 99 KG