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

Catalog Number	LITNGFHT100BER
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system flash aspiration catheter (flash catheter) and a non-penumbra sheath.During the procedure, the physician completed one pass using the flash catheter.While torquing the flash catheter back and forth, the distal end of the flash catheter kinked in the inferior vena cava (ivc).When withdrawing the flash catheter, the distal end of the catheter was noticed to be in the patient's heart.The distal end of the flash catheter was removed by using a snare device.The procedure was completed using a new flash catheter and a new non-penumbra sheath.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
Please note that the following section has been updated.1.Section b.Box 5.Describe event or problem.Evaluation of the returned indigo system flash aspiration catheter (flash catheter) confirmed it was fractured.The flash catheter was also kinked and torqued at the fractured location.If the flash catheter is forcefully torqued and manipulated against resistance, damage such as a fracture may occur.Further evaluation revealed a kink on the catheter.This damage was incidental to the complaint and the root cause could not be determined.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system flash aspiration catheter (flash catheter), an indigo system lightning flash aspiration tubing (flash tubing), and a non-penumbra sheath.During the procedure, the physician completed one pass using the flash catheter.The flash catheter became kinked distal to the sheath in the inferior vena cava (ivc) when being torqued and manipulated back and forth.The flash catheter then fractured at the kinked location when retracted into the sheath.The distal end of the flash catheter was snared.The procedure was completed using a new flash catheter and a new non-penumbra sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM FLASH ASPIRATION CATHETER
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda 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: 22162120
• Report Number: 3005168196-2025-00193
• Device Sequence Number: 21043314
• Product Code: QEW
• UDI-Device Identifier: 00815948029446
• UDI-Public: 00815948029446
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K240030
• 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): 07/18/2025

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: LITNGFHT100BER
• Device Lot Number: F00015471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 07/18/2025
• 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: 75 YR
• Patient Sex: Male