MAUDE Adverse Event Report: NUMED, INC. NUCLEUS-X CATHETER; AORTIC VALVULOPLASTY CATHETER

Model Number	230X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional 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 physician stated that he was not surprised the balloon ruptured because the aortic valve was heavily calcified and shaped like a dagger.There were no issues with the patient after the procedure.The balloon burst was attributed to the patient's anatomy.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 6 atm, which is well above the labeled rbp of 3 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.
Event or Problem Description
Balloon burst.

• Brand Name: NUCLEUS-X CATHETER
• Common Device Name: 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 12967 ; 3153284491
• MDR Report Key: 17143303
• Report Number: 1318694-2023-00003
• Device Sequence Number: 1868865
• Product Code: OZT
• UDI-Device Identifier: 04046964340086
• UDI-Public: 04046964340086
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: 230X
• Device Catalogue Number: PVN406
• Device Lot Number: NX-2515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown