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

Model Number	CAT6
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the anterior tibial artery using an indigo system aspiration catheter 6 (cat6).During the procedure, the cat6 was advanced over the guidewire and into the target vessel.The guidewire was then removed, and the first pass was completed using the cat6.Subsequently, the physician experienced resistance when reintroducing the guidewire back into the cat6; therefore, the cat6 and guidewire were removed as a system.Consequently, the physician noticed the distal tip of the cat6 to be kinked when retracting the guidewire out from the cat6.Therefore, the cat6 was no longer used for the remainder of the procedure.The procedure was complete using a new cat6.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: 11780197
• Report Number: 3005168196-2021-00966
• Device Sequence Number: 3647183
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2021
• 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: 08/18/2023
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F99615
• 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: 04/07/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005