MAUDE Adverse Event Report: NUMED, INC. Z-MED II CATHETER; PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER

Model Number	305
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint received through a medwatch report from the fda.The medwatch report had very little information and the user facility wished to remain anonymous so no additional information could be requested.No device was returned so the complaint could not be confirmed.No additional information is available.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 the balloons used on this device.No other complaints were associated with the tubing used to manufacture the balloons.A comparative catheter was pulled and tested.The device was the same catalog number but from a different lot number.The balloon was immersed in a body temperature water bath and inflated until it failed.The comparative catheter balloon did not burst until 9 atm, which is more than double the labeled rated burst pressure of 4 atm.No additional investigation can be performed due to the lack of information.No root cause established as the complaint could not be confirmed.Duplication of the issue required the balloon to be taken to double the labeled rated burst pressure.
Event or Problem Description
As received from the fda on a medwatch report - z-med balloon ruptured upon inflation during pulmonic valvuloplasty.

• Brand Name: Z-MED II CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL 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: 19974353
• Report Number: 1318694-2024-00005
• Device Sequence Number: 7075210
• Product Code: OZT
• UDI-Device Identifier: 04046964337611
• UDI-Public: 04046964337611
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

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 Model Number: 305
• Device Catalogue Number: PDZ663
• Device Lot Number: ZZ-15739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• 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 Sex: Unknown