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

Catalog Number	RED72
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	08/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a neuron max 6f 088 long sheath (neuron max), and a guidewire.It should be noted that the patient's anatomy was tortuous.During the procedure, while retracting the red72 during the first pass, the physician experienced resistance.The red72 was then found to be stretched and fractured at the proximal end.Therefore, the neuron max and the red72 were removed together, and the red72 was then removed from the neuron max.The procedure was completed with the same neuron max and a stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed a fracture near its proximal end, and the support coils unraveled at the fracture site.The unravelling of the support coils is likely the reported stretching.Further evaluation revealed a yield mark near the fractured site, indicating that the red72 was kinked prior to fracturing.If the red72 is retracted against resistance at an angle, damage such as a kink and subsequent fracture may occur, causing the support coils to unravel during further retraction.It was reported that the patient's anatomy was tortuous.This likely contributed to the resistance during retraction of the red72.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: 20375275
• Report Number: 3005168196-2024-00335
• Device Sequence Number: 6868989
• Product Code: NRY
• UDI-Device Identifier: 00815948023918
• UDI-Public: 00815948023918
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024
• 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: RED72
• Device Lot Number: H00004436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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: 53 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005