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

Catalog Number	LITNGBT7TQ130
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the arteriovenous (av) fistula using an indigo system aspiration catheter 7 (cat7), indigo system lightning bolt aspiration tubing (lightning bolt aspiration tubing), and a 7f sheath.During the procedure, the physician completed approximately three passes in the target location using the cat7.The cat7 was removed out from the sheath to be flushed.While advancing the cat7 for the next pass, the physician noticed the cat7 would not remain straight and had folded back into the access point due to the placement of the cat7.The cat7 would no longer advance in the vessel.Therefore, the physician removed the cat7 and noticed the distal end of the cat7 had fractured and remained in the vessel.The physician attempted to remove the fractured distal end of the cat7 using a snare device, but the attempt was unsuccessful.The sheath was then removed, and it was discovered that the fractured portion of the cat7 was attached to the sheath.Both the sheath and fractured portion of the cat7 were removed together.The procedure was completed using a new cat7 and the same lightning bolt aspiration tubing.There was no report of an adverse effect to the patient.
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.

• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21028410
• Report Number: 3005168196-2024-00427
• Device Sequence Number: 9133643
• Product Code: QEW
• UDI-Device Identifier: 00815948025462
• UDI-Public: 00815948025462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: H00004316
• 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: 12/03/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• 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 Age: 71 YR
• Patient Sex: Unknown