MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Model Number RED72KIT-A

Device Problem Break (1069)

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

Event Date 01/27/2022

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the vertebral artery using a penumbra system red72 reperfusion catheter (red72) and a non-penumbra sheath.During the procedure, the physician broke the red72 and it began to unravel.Therefore, the red72 was removed.The procedure was completed using a new red72.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the red72 confirmed that the catheter was fractured.This damage typically occurs if the catheter is forcefully retracted against resistance.If the catheter is retracted against resistance, the catheter may begin to stretch.Subsequent retraction against resistance may cause the catheter to eventually fracture.Further evaluation revealed ovalization on the proximal end of the catheter shaft.This damage was incidental to the reported complaint.Penumbra catheters 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.

• Brand Name: PENUMBRA SYSTEM RED 72 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: 13579643
• MDR Text Key: 287926874
• Report Number: 3005168196-2022-00076
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 00815948023932
• 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: 01/01/2005,02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RED72KIT-A
• Device Catalogue Number: RED72KIT
• Device Lot Number: F108316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• 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: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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