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

Model Number	105
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint catheter was returned for evaluation.There is a longitudinal tear in the balloon.The balloon was examined at 10x magnification, but nothing was seen that could have caused the balloon tear.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 and lot number as the complaint device.The balloon was immersed in a body temperature water bath and inflated until it failed.The comparative catheter balloon did not burst until 4.5 atm, which is more than double the labeled rated burst pressure of 2 atm.It is unknown if an inflation device with pressure gauge was used, and what pressure the balloon was taken to.The procedure is also unknown, however, for a patient to aspirate contrast, the procedure had to involve the respiratory system.This device is only indicated for use in the cardiovascular system - pulmonary valvuloplasty.The root cause is being attributed to the off label use of the device.The comparative catheter did not burst until it was taken to more than double it's labeled burst pressure.This comparative catheter was from the same lot as the complaint catheter.
Event or Problem Description
The balloon was inflated and burst, causing the patient to aspirate contrast.

• Brand Name: TYSHAK 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: 24885507
• Report Number: 1318694-2026-00002
• Device Sequence Number: 15908623
• Product Code: LIT
• UDI-Device Identifier: 04046964339219
• UDI-Public: 04046964339219
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/15/2026

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
• Operator of Device: Health Professional
• Device Model Number: 105
• Device Catalogue Number: PDC530
• Device Lot Number: TT-22120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2025
• 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
• Patient Sex: Unknown