MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number	RED62S
Medical Device Problem Codes	Unraveled Material (1664); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned red62 confirmed the reported complaint.Evaluation revealed that the catheter was stretched, fractured and the internal coil winds were unraveled at the fracture site.This damage typically occurs if the red62 is retracted against resistance during use.Further evaluation revealed that the red62 was ovalized distal to the fractured location, and the returned non-penumbra access catheter was kinked.If the non-penumbra access catheter is kinked while the red62 is inside, the red62 may become pinned within the kinked location.If the red62 is retracted while pinned, it may become ovalized, stretched and subsequently fractured.The root cause of the kink on the non-penumbra access catheter could not be determined.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a non-penumbra access catheter, a non-penumbra aspiration catheter, a non-penumbra microcatheter, a stent retriever, and a guidewire.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the non-penumbra aspiration catheter and the stent retriever to the target location and completed one pass.It was reported that the access catheter was removed at some point.The physician attempted to complete a second pass without success.The non-penumbra aspiration catheter and the guidewire was then exchanged for a red62 and another guidewire.The red62 and the stent retriever were then advanced through the second access catheter to the target location; however, the red62 was not moving.It was reported that the access catheter kicked back.The physician then removed the red62, the second access catheter, the stent retriever, and the second guidewire.Upon removal, the physician noticed that the access catheter was kinked at the midshaft and the red62 had unraveled at the midshaft toward the proximal end.The physician then used a new non-penumbra access catheter, a new non-penumbra aspiration catheter, and a microwire and completed three passes.A contrast run was performed, and a large perforation was noticed at the distal m2 segment of the mca.It was reported that the red62 was not advanced out of the access catheter and was never made it to the mca where the perforation was noticed.It was reported that the patient coded in the intensive care unit (icu).The patient current medical status is unknown.

• Brand Name: PENUMBRA SYSTEM RED 62 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: 19241969
• Report Number: 3005168196-2024-00171
• Device Sequence Number: 7355755
• Product Code: NRY
• UDI-Device Identifier: 00815948023475
• UDI-Public: 815948023475
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203440
• 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): 05/03/2024
• 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 Catalogue Number: RED62S
• Device Lot Number: F00010256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• 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: 04/08/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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: 85 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005