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	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The comparative catheter was pulled and tested for rbp.The labeled rbp for this device is 2.0 atm.The comparative catheter did not burst until 3.5 atm.As specified in the report, it is unknown as to what pressure the complaint catheter burst at.Most balloon bursts are contributed to over pressurization of the balloon.The physician did not used an inflation device with pressure gauge as is recommended in the instructions for use.The inflation device with pressure gauge is recommended to monitor the pressure, so that the rbp is not exceeded.Device not returned.
Event or Problem Description
As per the report from bis - "during a valvuloplasty procedure, physician had the balloon rupture upon inflation.There was not harm caused to the patient and the procedure ended up with a good result, despite this rupture.The cardiac output prior to the procedure was a 1.6 and after the procedure it was an avg of 1.95.Calcification was noted at the procedure site.An inflation device with pressure gauge was not used.The atm at which the balloon ruptured is unknown because a syringe was used.The catheter shaft was not kinked.A 9f terumo pinnacle sheath was used.No unusual patient anatomy was reported.".

• 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: 6669240
• Report Number: 1318694-2017-00019
• Device Sequence Number: 16161115
• Product Code: LIT
• UDI-Device Identifier: 04046964339417
• UDI-Public: 04046964339417
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/27/2017

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: Physician
• Device Expiration Date: 04/30/2022
• Device Model Number: 105
• Device Catalogue Number: PDC540
• Device Lot Number: TT-12561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1