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

Model Number	105
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As per the report from the user facility / distributor - during scheduled right heart catheterization and balloon angioplasty of pulmonic valve, tyshak ii 18.0mmx4.0mm balloon inflated to burst pressure of 2.0 atm.Balloon ruptured.Tip of the balloon sheared away from body of balloon catheter and remained in body as catheter removed.Intracardiac echo initiated in attempt to visualize retained balloon tip.Unable to obtain any images.Alternate balloon used to complete procedure.Procedure ended.
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.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.The root cause of this failure is unknown.The device was not returned so the complaint could not even be confirmed.Request for the device did not result in the return of the device.Additional questions were sent to the distributor / user facility; however, no additional information was received.

• Brand Name: TYSHAK II VALVULOPLASTY 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: 23381688
• Report Number: 1318694-2025-00007
• Device Sequence Number: 17369059
• Product Code: LIT
• UDI-Device Identifier: 04046964339172
• UDI-Public: 04046964339172
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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-21665
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• 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: Other
• Patient Sex: Unknown