MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED43 REPERFUSION CATHETER; NRY

Catalog Number	RED43160
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
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 right m2 segment of the middle cerebral artery (mca) using a penumbra system red 43 reperfusion catheter (red43), a penumbra system red 62 reperfusion catheter (red62), and a benchmark bmx96 access system (bmx96).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician made three passes in the target location using the red43 and red62.While attempting to make the next pass, it was reported the physician applied more than usual force to the coaxial system and the distal end of the red43 kinked while inside the bmx96.While retracting the red43, the physician experienced resistance and fractured the red43 at the distal end.The fractured distal segment of the red43 was removed using a snare device.The procedure was completed using a new red43, the same red62, and the same bmx96.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED43 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 19315445
• Report Number: 3005168196-2024-00184
• Device Sequence Number: 3088460
• Product Code: NRY
• UDI-Device Identifier: 00815948025745
• UDI-Public: 815948025745
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2024
• 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: 09/25/2026
• Device Catalogue Number: RED43160
• Device Lot Number: F00008653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 04/19/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005