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

Catalog Number RED72

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the left common carotid artery (cca) and the left middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra guide catheter, and a guidewire.During the procedure, while the physician advanced the red72 over the guidewire through the guide catheter for the first pass, the physician noticed under fluoroscopy that the guidewire was not visible even though the physician was pushing forward the guidewire.The physician then decided to remove the red72 from the guide catheter to see the guidewire.While removing the red72, the physician experienced resistance.After removal of the red72, the physician noticed that the distal length of the red72 had fractured in two locations.It was reported that the guidewire had exited through the side of the red72 instead of the distal end of the red72.Therefore, red72 was not used for the remainder of the procedure.The procedure was completed using another aspiration catheter, the same guide catheter, and the same guidewire.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER
• Type of Device: 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: 19107963
• MDR Text Key: 340819782
• Report Number: 3005168196-2024-00144
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023925
• UDI-Public: 815948023925
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RED72
• Device Lot Number: H00002573
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female