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

Catalog Number	LITNGFHT115BER
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned flash catheter confirmed the fracture.Evaluation revealed a kink proximal to the fractured location on the flash catheter and a fractured segment of the non-penumbra sheath returned on the flash catheter.If the flash catheter is torqued against resistance, damage such as a fracture may occur.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed that the distal end of the returned non-penumbra sheath was folded inward on the flash catheter.This may have contributed to some resistance while manipulating the flash catheter through the non-penumbra sheath during the procedure.The proximal fractured segments of both devices were not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a deep vein thrombosis (dvt) using an indigo system aspiration flash catheter (flash catheter), an indigo system lightning flash aspiration tubing (flash tubing), a non-penumbra sheath.During the procedure, the physician completed one pass using the flash catheter.The physician then torqued the flash catheter through the sheath and noticed that the flash catheter was stuck within the sheath.It was reported that the flash catheter appeared to be fractured at the midshaft under fluoroscopy.The flash catheter and the sheath were removed together and were not used for the remainder of the procedure.The procedure was completed using a new flash catheter, the same flash tubing, 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 CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 18256526
• Report Number: 3005168196-2023-00536
• Device Sequence Number: 15251672
• Product Code: QEW
• UDI-Device Identifier: 00815948024892
• UDI-Public: 815948024892
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K222358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2023
• Report Date (Section F): 01/01/2005

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: 05/04/2026
• Device Catalogue Number: LITNGFHT115BER
• Device Lot Number: F00006598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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 Age: 60 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005