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

Catalog Number	LITNGFXT100H1
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 left iliac and left common femoral veins using an indigo system flash aspiration catheter (flash catheter), an element vascular access sheath (element) and a guidewire.It should be noted that the patient had bilateral iliac stents.During the procedure, the physician used contralateral access and completed two passes using the element sheath and the flash catheter.The element was not providing good support; therefore, the physician exchanged the element with a non-penumbra sheath and completed one pass.The physician experienced resistance while advancing the flash catheter through the sheath and noticed under fluoroscopy that the sheath and the flash catheter were kinked.While attempting to retract the flash catheter, the flash catheter fractured at the mid shaft.The physician removed the fractured part of the flash catheter by inflating a balloon in the sheath.It was reported that there was a steep bifurcation in the iliac stents, which made for an acute angle to navigate.The angle may have caused the non-penumbra sheath to kink.The procedure was aborted at this point.It was reported that the patient had a vagal response to the physician trying to remove the device and a drop in the heart rate.Advanced cardiovascular life support (acls) protocol was followed.A temporary venous pacemaker was put in that was removed before the patient left the room and a defibrillator was used at least once.The patient recovered from this with no issues.

• Brand Name: INDIGO SYSTEM FLASH 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22205758
• Report Number: 3005168196-2025-00203
• Device Sequence Number: 6764703
• Product Code: QEW
• UDI-Device Identifier: 00815948029866
• UDI-Public: 00815948029866
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K241399
• 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): 06/13/2025

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: LITNGFXT100H1
• Device Lot Number: F00014203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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