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

Catalog Number RED62SKIT

Device Problem Fracture (1260)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a velocity delivery microcatheter (velocity), a benchmark bmx96 access system (bmx96), a stent retriever and a guidewire.During the procedure, the physician advanced the stent retriever using the velocity and the red62 to the target location.The physician then removed the guidewire and the velocity and trapped the clot inside the stent retriever.It was reported that the physician corked the stent retriever outside the red62 and then removed the stent retriever and the red62 together.Upon removal, the distal end of the red62 was noticed to be fractured but remained connected.The procedure was completed at this point and thrombolysis in cerebral infarction (tici) grade 3 was achieved.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned red62 confirmed that the device was fractured.Evaluation also revealed that a non-penumbra stent retriever was retracted into the red62.If the stent retriever and red62 are forcefully manipulated against resistance during retraction, damage such as a fracture may occur.Penumbra products 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.H3 other text : placeholder.

• 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: 17514430
• MDR Text Key: 321714302
• Report Number: 3005168196-2023-00386
• 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
• Report Date: 01/01/2005,08/11/2023

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
• Device Catalogue Number: RED62SKIT
• Device Lot Number: F00000427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• 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: 07/18/2023
• Initial Date FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• 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: 68 YR
• Patient Sex: Female