MAUDE Adverse Event Report: NUMED, INC. TYSHAK II VALVULOPLASTY CATHETER; PERCUTANEOUS TRANSLUMINAL VALULOPLASTY CATHETER

Model Number	105
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
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 the balloons used on this device.No other complaints were associated with the tubing used to manufacture the balloons.Review of data from the user facility shows that the device was being used off-label for aortic valvuloplasty.This catheter is only approved for pulmonary valvuloplasty.It is unknown as to what pressure the balloon was taken to and what pressure the balloon burst at.An inflation device with pressure gauge was used, however, the facility states that they do not monitor the pressure.Instead, they visualize how well the balloon expands under fluoroscopy.The following warning is listed in the ifu - "caution: 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." 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 4 atm, which is double the labeled rated burst pressure of 2 atm.
Event or Problem Description
During a valvuloplasty, the balloon ruptured.

• Brand Name: TYSHAK II VALVULOPLASTY CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL VALULOPLASTY 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: 19806914
• Report Number: 1318694-2024-00004
• Device Sequence Number: 20929894
• Product Code: LIT
• UDI-Device Identifier: 04046964339172
• UDI-Public: 04046964339172
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K003052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 105
• Device Catalogue Number: PDC528
• Device Lot Number: TT-19526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White