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

Model Number	302.1
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint reported to numed through their distributor bis / fda medsun report.Repeated attempts to get more information did not result in any additional information.It is unknown as to what pressure the device was taken to, and whether or not an inflation device with pressure gauge was used as indicated in the instrucitons for use.This complaint could not be confirmed as the device was not returned for investigation.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.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 burst in a longitudinal direction at 6atm.Well above the labeled rated burst pressure of 2.0 atm.The complaint could not be duplicated with the comparative catheter, and the device performed as intended.
Event or Problem Description
Received by distributor through the medsun reporting.While deploying the z-med balloon inside the valve it ruptured.It was then wrapped around the wire in the patient.The physician was able to pull the balloon out with difficulty, and the sheath in the groin was bent during the extraction process.

• Brand Name: Z-MED CATHETER
• Common Device Name: BALLOON 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: 21775531
• Report Number: 1318694-2025-00002
• Device Sequence Number: 15509037
• Product Code: OZT
• UDI-Device Identifier: 04046964338366
• UDI-Public: 04046964338366
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial

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 Expiration Date: 10/31/2025
• Device Model Number: 302.1
• Device Catalogue Number: SO046
• Device Lot Number: Z-8956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male