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

Catalog Number	RED62S
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 right m1 segment of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red 62), a stent retriever, a balloon guide catheter, a non-penumbra sheath, and a guidewire.During the procedure, after completing the first pass using the stent retriever and the balloon guide catheter, the clot migrated to the distal m2 segment of the mca.The physician then used the red 62 with the same sheath to perform a direct aspiration pass and successfully removed the clot after one pass.While retracting the red 62 from the patient, the physician experienced resistance.After removing the red 62, the physician found that red 62 was fractured at the distal length.At this point, no additional passes were required and the procedure was successfully completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red62 confirmed a fracture on its distal shaft.This type of a kink and subsequent fracture may occur, if the red62 is retracted against resistance.Based on the reported event, the root cause of the resistance could not be determined.Further evaluation of the device revealed ovalization along the length of the catheter and a kink on its distal shaft.This damage is incidental to the complaint and the root cause of this 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.

• 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: 20457288
• Report Number: 3005168196-2024-00348
• Device Sequence Number: 8701671
• Product Code: NRY
• UDI-Device Identifier: 00815948023475
• UDI-Public: 00815948023475
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K203440
• 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: RED62S
• Device Lot Number: H00004962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2024
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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: 67 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005