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

Model Number	105
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As per the report from the user facility / distributor - patient brought in for a valuvloplasty.During the procedure the valvuloplasty balloon ruptured.Tyshak 22mm aortic balloon ruptured while inflated across tavr aortic valve.We believe that the tavr strut caught the balloon.During inflation, the syringe filled with blood and the balloon was noted to be ruptured.Some of the balloon got caught on the artificial valve.A 50cc syringe with a 3 way stopcock was used.Monitored balloon inflation under fluoro.Introducer 7fr x 10cm terumo.Guidewire:.035 x 260 lunderquist.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.Preexisting characteristics that may have contributed to the event: coronary heart disease.The patient's condition post procedure: stable, transferred to cardiovascular icu.Another balloon was not used to complete the procedure.
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.The complaint catheter was returned in a biohazard bag.The catheter is bloody.The guidewire is in the catheter.There is a lateral tear in the balloon.The inner tubing has been stretched over the guidewire under the balloon.The distal end of the balloon is detached.The missing section was not returned.A comparative catheter was tested.This catheter was the same catalog number, but a different lot number.The balloon was immersed in a body temperature water bath and inflated until it failed.The comparative catheter did not burst until 3 atm, which is more than the labeled rated burst pressure of 2 atm.There was a longitudinal tear in the balloon.The burst may have been caused by the bioprosthetic valve that was being dilated.The valve also appears to have played a role in the balloon piece detachment.The catheter was being used off label.The balloon was being used to dilate the aortic valve.Tyshak ii's are approved for ptv of the pulmonary valve.An inflation device with pressure gauge was not used, making it impossible to determine the pressure reached at failure.A 7fr introducer was used during the procedure.Pdc537's are rated for use with an 8fr introducer.

• 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: 12719173
• Report Number: 1318694-2021-00010
• Device Sequence Number: 19829336
• Product Code: LIT
• UDI-Device Identifier: 04046964339356
• UDI-Public: 04046964339356
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/29/2021

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: 05/31/2026
• Device Model Number: 105
• Device Catalogue Number: PDC537
• Device Lot Number: TT-16835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR