MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED62 REPERFUSION CATHETER; NRY

Device Problems Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned red62 confirmed that the catheter was fractured.If the red62 is retracted against resistance, damage such as a fracture may occur.The kink in the bmx81 may have contributed to resistance.Further evaluation revealed a kink on the distal fractured segment.This damage was incidental to the reported complaint and likely occurred during snaring of the device.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 1.3005168196-2023-00566 h3 other text : placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the venous sinus using a penumbra system red 62 reperfusion catheter (red62), a benchmark bmx81 access system (bmx81), a velocity delivery microcatheter (velocity), a non-penumbra sheath (7fr) and a guidewire.It should be noted that the patient''s anatomy was tortuous and there was a stenosis in the anatomy.During the procedure, the physician gained access from the right groin using the 7fr sheath.While advancing the triaxial system (bmx81, red62, velocity, guidewire) to cross the stenosis, the red62 and bmx81 met resistance and the system kinked.Subsequently, the bmx81 and red62 fractured.A snare was advanced through the 7fr sheath to snare and hold onto the red62 and bmx81.However, the 7fr sheath was too small to pull and snare the catheters out.Therefore, the left groin was accessed with a larger non-penumbra sheath (14fr) and an additional snare was used to remove the bmx81 and red62.The procedure was completed using a new red62, bmx81, velocity and guidewire.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED62 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: 18395686
• MDR Text Key: 331676835
• Report Number: 3005168196-2023-00565
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/26/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• 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
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female