MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED72 REPERFUSION CATHETER; NRY

Catalog Number RED72KIT

Device Problem Fracture (1260)

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

Event Date 05/24/2023

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned red72 confirmed that the catheter was fractured.If the red72 is mishandled during use, damage such as a kink and subsequent fracture may occur.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.H3 other text: placeholder.

Event Description

The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72) and a non-penumbra sheath.During the procedure, after the red72 was advanced in the patient for the first pass and hooked up for aspiration, the physician noticed that the red72 was aspirating air.Subsequently, the red72 was found to be fractured at the hub.Therefore, the red72 was removed.The procedure was completed using a non-penumbra catheter and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED72 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: 17195473
• MDR Text Key: 317954925
• Report Number: 3005168196-2023-00298
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 815948023932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211654
• 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: 01/01/2005,06/23/2023

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: RED72KIT
• Device Lot Number: H00000778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• 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: 05/31/2023
• Initial Date FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• 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