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

Model Number	105
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As per the report from the facility, this device was being used off-label.It is indicated for percutaneous valvuloplasty only and was being used for a tavr procedure, where two stents had been previously placed.The instructions for use states that an inflation device with pressure gauge should be used to monitor pressure, so that the rbp of the balloon is not exceeded.The physician used a syringe to inflate this balloon and it is unknown as to what pressure the balloon was taken.The comparative catheter that was pulled and tested, was inflated to the labeled rbp of 2.0 atm with no issues.Greater pressure was applied to the balloon, and it did not burst until 4 atm.
Event or Problem Description
As per the report received from bis: "balloon was inflated with a syringe and burst.Physician was using the balloon for tavr - existing stent inside stent in valve when balloon was inflated.A 14fr dry seal introducer sheath was used.The catheter shaft was not kinked.A tyshak ii was used to complete the procedure without incident.The patient was fine post procedure - the patient had 2 stents in the valve.".

• Brand Name: TYSHAK II
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6230017
• Report Number: 1318694-2017-00001
• Device Sequence Number: 18943458
• Product Code: DQY
• UDI-Device Identifier: 04046964339172
• UDI-Public: 04046964339172
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/06/2017

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: No Information
• Device Expiration Date: 10/31/2021
• Device Model Number: 105
• Device Catalogue Number: PDC528
• Device Lot Number: TT-12193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1