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

Model Number	105
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter was returned and is clean.It was not used on a patient.A longitudinal tear in the balloon was confirmed.The cause could not be identified through microscopic inspection.A comparative catheter was tested for rated burst pressure.It was the same catalog number / size as the complaint catheter, but a different lot number.The balloon was immersed in a body temperature water bath and inflated in 0.5 atm increments until failure.The balloon tore in a longitudinal manner at 3.5 atm, which is well above the labeled rated burst pressure of 2.0 atm.As per the instructions for use, an inflation device with pressure gauge should be used on the device to monitor pressure.In this case, an inflation device with pressure gauge was not used, making it impossible to determine how much pressure was applied to the balloon before it burst.
Event or Problem Description
As per the report from the user facility / distributor - during positive balloon preparation as indicated in the ifu, the physician filled the balloon with contrast/saline mixture (ration unknown) to a "soft" dilated state with either a 30 or 60cc syringe.Upon "pullback" to expel air, the physician noted that the balloon burst.The nature of this burst was not known.The catheter shaft was not kinked.A 611937 pdc537 was used to complete the procedure.It is unknown at what pressure the balloon ruptured.

• Brand Name: TYSHAK II
• Common Device Name: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 9449891
• Report Number: 1318694-2019-00025
• Device Sequence Number: 10842698
• Product Code: LIT
• UDI-Device Identifier: 04046964339257
• UDI-Public: 04046964339257
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K003052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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 Expiration Date: 09/30/2024
• Device Model Number: 105
• Device Catalogue Number: PDC532
• Device Lot Number: TT-15152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1