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

Model Number	105
Medical Device Problem Codes	Break (1069); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record was performed and no issues were found.All devices within the lot met all requirements for release and distribution.There have been no other complaints associated with this lot number.A review of the balloon material used shows there are no other complaints associated with the balloon material used to manufacture the balloons used on this lot of catheters.This device was being used off label for an unapproved indication.The approved indication is pulmonary valvuloplasty.This device was being used for an aortic valvuloplasty procedure.A comparative catheter was pulled and tested for rated burst pressure.The comparative catheter was the same catalog number but different lot number, and was manufactured using the same balloon material lot number as the complaint catheter.The balloon was immersed in a body temperature bath and inflated until it burst.The catheter did not burst until 4.5 atm, which is well above the labeled rated burst pressure of 2.0 atm.
Event or Problem Description
As reported to numed by the user facility / distributor - " bav procedure.There was a brief inflation and then the balloon burst.Account indicated that the procedure was successful.The entire balloon was removed after the rupture.An inflation device with a pressure gauge was used.Physician does not know what number it was on when it burst.The guidewire used was 0.035.It is unknown whether or not the shaft was kinked or if there was anything unusual with the patient anatomy.The patient was fine post procedure." "there was a brief inflation and then the balloon burst." no adverse events reported.

• Brand Name: TYSHAK II CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 10780042
• Report Number: 1318694-2020-00011
• Device Sequence Number: 16898051
• Product Code: LIT
• UDI-Device Identifier: 04046964339219
• UDI-Public: 04046964339219
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2020

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: 02/28/2024
• Device Model Number: 105
• Device Catalogue Number: PDC530
• Device Lot Number: TT-14537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1