MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Model Number	CAT6KIT-A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned cat6 revealed that the catheter was fractured, and the complaint was confirmed.The probable cause of the reported failure is likely due to forceful retraction against resistance, based on the damage at the fractured location.If the cat6 is forcefully retracted against resistance during use, damage such as a fracture may occur.Further evaluation revealed kinks and ovalization on the fractured distal segment.This damage was incidental to the reported complaint, and the root cause could not be determined; however, this damage may have contributed to resistance during removal of the cat6.The complaint did not involve any functional issues on the aspiration tubing, and therefore, no functional testing was performed.Penumbra products 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 in the superficial femoral artery (sfa) using an indigo system aspiration catheter 6 (cat6) and a non penumbra 6 fr guide sheath.During the procedure, the physician advanced the cat6 through the guide sheath and into the target location through a contralateral approach and aspirated some clot; however, the physician encountered some resistance.On the second pass, the physician encountered more resistance and thought that the cat6 had become stuck in a previously placed stent.While retracting the cat6, the physician encountered more resistance and subsequently noticed that the distal tip of the cat6 was separated but still intact.It was reported that the physician was able to retrieve the distal tip of the cat6 and the cat6 without any medical intervention.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12558222
• Report Number: 3005168196-2021-02165
• Device Sequence Number: 1113580
• Product Code: DXE
• UDI-Device Identifier: 00815948020405
• UDI-Public: 00815948020405
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2021
• 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: 11/02/2023
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F101684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• 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: 09/27/2021
• Initial Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005