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 02/23/2024

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 non-penumbra sheath, and a guidewire.During the procedure, the physician completed one pass using the red62.While aspirating using the red62 during the second pass, the physician noticed under fluoroscopy that the red62 was fractured.Therefore, the red62 was removed.The procedure was completed using a new red62 and the same sheath.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.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 04/11/2024: section a.Box 1.Patient identifier.Section b.Box 5.Describe event or problem.Evaluation of the returned red62 confirmed a fracture on the distal shaft.Further evaluation revealed a kink distal to the fracture and stretching proximal to the fracture.If the device is advanced against resistance, damage such as a kink may occur.Subsequently, if the device is retracted against resistance, damage such as stretching, and a fracture may occur.The root cause of resistance during the procedure 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 red 62 reperfusion catheter (red62), a non-penumbra sheath, and a guidewire.During the procedure, the physician completed one pass using the red62.While aspirating using the red62 during the second pass, the physician noticed under fluoroscopy that the distal length of the red62 was fractured.Therefore, the red62 was removed.The procedure was completed using a new red62 and the same sheath.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: 18947734
• MDR Text Key: 338560039
• Report Number: 3005168196-2024-00095
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023444
• UDI-Public: 815948023444
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K203440
• 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,Followup
• Report Date: 01/01/2005,04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: F00007702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• 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: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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