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

Model Number	230X
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Annex c - cause investigation - investigation findings - code 4256 was chosen - malfunction observed without conclusive findings.This term was added in august of 2023 but has not yet been added to this esubmitter database to be used in section h6.The complaint catheter was returned in a biohazard bag.There is a longitudinal tear in the balloon.Microscopic inspection did not reveal the cause of the failure.The balloon's waist appears to be completely expanded.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 it burst.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.It is unknown as to what pressure the balloon was taken to and if an inflation device with pressure gauge was used - as is recommended in the instructions for use.Cause could not be established due to the lack of information from teh user facility / distributor.
Event or Problem Description
As per the report received from the distributor / user facility - balloon was inflated and ruptured after being deflated.

• 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 12965 ; 3153284491
• MDR Report Key: 17737376
• Report Number: 1318694-2023-00008
• Device Sequence Number: 5889351
• Product Code: OZT
• UDI-Device Identifier: 04046964340024
• UDI-Public: 04046964340024
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 230X
• Device Catalogue Number: PVN403
• Device Lot Number: NX-2337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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