MAUDE Adverse Event Report: NUMED, INC. Z-MED CATHETER; AORTIC VALVULOPLASTY CATHETER

Model Number 302.1

Device Problem Break (1069)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record was performed and no issues were noted.There are no other complaints associated with this lot number of devices.A review was also performed on the balloon tubing used to manufacture these balloons.No other complaints were associated with the tubing used to manufacture the balloons.The complaint catheter was not returned so the complaint could not be confirmed.A request for additional information was sent (3) times by the distributor, and the requested information was not received.A comparative catheter was pulled and tested for rated burst pressure.The comparative catheter was the same catalog number but a different lot number as the complaint catheter.The balloon was immersed in a body temperature bath and incrementally inflated until it burst.The balloon did not burst until 8 atm, which is well above the labeled rbp of 4 atm.The complaint could not be duplicated with the comparative catheter when taken to the rated burst pressure.The balloon had to be over pressurized to 2x the labeled rated burst pressure before we could get it to burst.Based on historical data, most balloon bursts are caused by over pressurization of the balloon.It is unknown as to what pressure this catheter/balloon was taken to when it burst.There is a warning in the instructions for use that states: warning - do not exceed the rbp.An inflation device with pressure gauge is recommended to monitor pressure.Pressure in excess of the rbp can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.

Event Description

As reported from the user facility / distributor - balloon burst with inflation.

• Brand Name: Z-MED CATHETER
• Type of Device: AORTIC VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 15887515
• MDR Text Key: 307703577
• Report Number: 1318694-2022-00013
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 04046964329012
• UDI-Public: 04046964329012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 302.1
• Device Catalogue Number: PDZ320
• Device Lot Number: Z-9900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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