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

Catalog Number RED62SKIT

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

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system red62 reperfusion catheter (red62), a velocity delivery microcatheter (velocity), a non-penumbra balloon guide catheter, and a guidewire.During the procedure, while retracting the red62, the physician experienced resistance.Upon removal from the patient''s body, the red62 was noticed to be fractured.Therefore, the red62 was not used for the remainder of the procedure.It was reported that the balloon guide catheter was unable to advance to the target location.No additional information regarding the procedure was provided.There was no report of an adverse effect to the patient.

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.H3 other text : placeholder.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 12jan24: 1.Section a.Box 1.Patient identifier.2.Section e.Box 4.Initial reporter also sent report to fda h3 other text : placeholder.

Manufacturer Narrative

Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 01/12/2024: 1.Section b.Box 5.Describe event or problem evaluation of the returned red62 confirmed that the catheter was fractured and revealed stretching at the fractured location.If the red62 is retracted against resistance, the device may become stretched and subsequently fracture.Based on the reported event, the root cause of resistance could not be determined.Further evaluation of the device revealed multiple kinks on the distal shaft.This damage was incidental to the complaint and the root cause of this damage 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.

Event Description

The patient was undergoing a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra system red62 reperfusion catheter (red62), a velocity delivery microcatheter (velocity), a non-penumbra balloon guide catheter, and a guidewire.It was reported that the balloon guide catheter was unable to advance to the target location.During the procedure, after completing three passes using the red62, the physician removed the red62 from the patient¿s body against resistance.After removal, the red62 was noticed to be fractured near the hub.Therefore, the red62 was not used for the remainder of the procedure.The procedure was completed using a penumbra system red 72 reperfusion catheter (red72), the same velocity, and the same balloon guide catheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED 62 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: 18479793
• MDR Text Key: 332998456
• Report Number: 3005168196-2024-00022
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023536
• UDI-Public: 815948023536
• 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,Followup,Followup
• Report Date: 01/01/2005,03/13/2024

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
• Device Catalogue Number: RED62SKIT
• Device Lot Number: F00007281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• 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: 12/12/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 12/21/2023; 01/14/2005
• Supplement Dates FDA Received: 01/16/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• 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: 94 YR
• Patient Sex: Female