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

Catalog Number	RED72KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) and the m1 segment of the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a penumbra system red 43 reperfusion catheter (red43), a benchmark bmx96 access system (bmx96), a non-penumbra sheath (8f terumo), and a guidewire.During the procedure, the physician completed one pass using the red72.While attempting to remove the red72 from the bmx96 after completion of the first pass, the physician noticed that the red72 unraveled and fractured at the distal end under fluoroscopy.It was reported that the bmx96 was herniating into the external carotid artery (eca) due to the patient¿s anatomy.The bmx96 containing the fractured distal portion of the red72 was removed and the fractured portion of the red72 was then removed from the bmx96 on the back table.The procedure was completed using another red72, the same red 43, the same bmx96, the same sheath, and the same guidewire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed that the catheter was fractured.If the red72 is retracted against resistance, damage such as a fracture may occur.Based on the reported event, the patient¿s anatomy may have contributed to resistance during the procedure.Further evaluation revealed bends along the length of the catheter shaft.The damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.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: 20652628
• Report Number: 3005168196-2024-00380
• Device Sequence Number: 8324997
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 00815948023932
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• 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): 11/11/2024
• 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: 11/17/2024
• Device Catalogue Number: RED72KIT
• Device Lot Number: F110881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• 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: 10/19/2024
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: 51 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005