MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number	RED72KIT
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72), a benchmark bmx96 access system (bmx96), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician placed the bmx96 into the patient.While advancing the red72 over the microcatheter and guidewire through the bmx96, the physician experienced resistance.The red72 would not advance past the carotid siphon.It was reported that the physician thought that the red72 reached the face of the clot.The physician then removed the microcatheter and guidewire and initiated aspiration.However, it was noticed that no thrombus was being removed and after two minutes under aspiration the physician began to retract the red72.Subsequently, resistance was encountered, but then the physician felt a reduction in resistance and was able to remove the red72.After removal, the physician noticed that the distal end of the red72 was unraveled but remained intact.Therefore, the red72 was not used for the remainder of the procedure.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68), the same bmx96, and the same microcatheter.There was no report of an adverse effect to the patient.
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.

• Brand Name: PENUMBRA SYSTEM RED 72 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: 16624823
• Report Number: 3005168196-2023-00141
• Device Sequence Number: 17710221
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 815948023932
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2023
• 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: 07/25/2025
• Device Catalogue Number: RED72KIT
• Device Lot Number: H00000780
• 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: 03/01/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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 Age: 53 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005