MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Model Number	CAT8XTORQ115KIT-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2020
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.This report is associated with mfr report number: 1.3005168196-2020-00650.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 8 (cat8) and non-penumbra sheath.During the procedure, the physician made several passes using the cat8 with little aspiration.Upon removal, the physician noticed a kink near the distal end of the cat8.A new cat8 was then inserted and several passes were made; however, upon removal, the physician noticed the cat8 to be kinked near the distal end.It was also reported that the physician experienced resistance while inserting both cat8s into the sheath.The physician then decided to change the sheath and realized that it was severely kinked due to the antegrade access and patient¿s anatomy.The procedure was then ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10060108
• Report Number: 3005168196-2020-00651
• Device Sequence Number: 19503161
• Product Code: DXE
• UDI-Device Identifier: 00815948020450
• UDI-Public: 00815948020450
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 04/27/2020
• 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: 10/03/2022
• Device Model Number: CAT8XTORQ115KIT-A
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H10083
• Was Device Available for Evaluation?: No
• 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: 04/27/2020
• Initial Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005