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

Catalog Number	RED72SDKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right m1 segment of the left middle cerebral artery (mca) using a penumbra system red72 reperfusion catheter (red72), a non-penumbra guide catheter, and a non-penumbra sheath.During the procedure, the physician completed one pass in the target location using the red72.After the pass, the physician noticed there was no significant flow under aspiration with the red72 and the red72 became clogged with clot.The physician decided to remove the red72; however, while removing the red72 out from the target location, the distal end of the red72 had fractured outside the tip of the guide catheter in the ophthalmic segment of the internal carotid artery (ica).Therefore, the physician made several attempts using the guide catheter under aspiration to successfully remove the fractured distal end of the red72 together with the guide catheter as a unit.The procedure was completed using a new guide catheter, non-penumbra aspiration catheter, non-penumbra microcatheter, and guidewire to achieve thrombolysis in cerebral infarction (tici) 3.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed that the device was fractured on the distal shaft.Evaluation revealed that the red72 was stretched at the fractured site and along the distal shaft.This damage typically occurs if the red72 is forcefully retracted against resistance.Based on the reported complaint, the root cause of this damage could not be determined.Further evaluation of the device revealed kinks throughout the length of the catheter shaft.This damage was incidental to the reported complaint.The kinks on the distal shaft likely occurred during removal of the device from the patient¿s body and kinks on the proximal shaft likely occurred during packaging for return to penumbra.Penumbra devices are visually 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: 20588655
• Report Number: 3005168196-2024-00371
• Device Sequence Number: 12399806
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 00815948025943
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/01/2024
• 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: RED72SDKIT
• Device Lot Number: F00012311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• 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: 10/10/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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