MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT5 ASPIRATION CATHETER; QEW

Model Number	CAT5KIT-A
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
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 distal branch of superior mesentric artery (sma) using an indigo system aspiration catheter 6 (cat6), indigo system cat5 aspiration catheter (cat5) and and a non-penumbra sheath (6.5 fr steerable).During the procedure,the physician made two passes successfully with the cat6; however during the third pass while advancing the cat6 without the guidewire, the cat6 kinked at the distal tip.Therefore, the cat6 was removed.At this point the physician decided to use the cat5 and upon removing the cat5 after the first pass, the physician noticed that the distal tip of the cat5 was kinked and stretched; therefore the cat5 was removed.The procedure was completed using an indigo system aspiration catheter 7 (cat7) and a non-penumbra sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT5 ASPIRATION CATHETER
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12104641
• Report Number: 3005168196-2021-01460
• Device Sequence Number: 11759490
• Product Code: QEW
• UDI-Device Identifier: 00815948020542
• UDI-Public: 00815948020542
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K192833
• 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): 07/01/2021
• 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: 07/01/2023
• Device Model Number: CAT5KIT-A
• Device Catalogue Number: CAT5KIT
• Device Lot Number: F98647
• 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: 06/03/2021
• Initial Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005