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

Model Number	105
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was being used off label for an unapproved indication.This catheter is only indicated for percutaneous valvuloplasty of the pulmonary valve.This device was being used for aortic valvuloplasty.An inflation device with pressure gauge was not used as specified in the instructions for use, so it is unknown as to what pressure this catheter was taken to.A comparative catheter was pulled and tested for rated burst pressure.This device was the same catalog number as the complaint catheter.The labeled rbp for the device is 2.0 atm.The comparative catheter was immersed in a body temperature bath and inflated until it failed.The catheter did not burst until 3.0 atm, which is above the labeled rbp.
Event or Problem Description
As per the report received from bis: "the product was used on the aortic valve.The balloon ruptured.A hand syringe inflation was used.".

• 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: 7201185
• Report Number: 1318694-2018-00001
• Device Sequence Number: 16437756
• Product Code: LIT
• UDI-Device Identifier: 04046964339295
• UDI-Public: 04046964339295
• 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): 01/17/2018

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: 08/31/2019
• Device Model Number: 105
• Device Catalogue Number: PDC534
• Device Lot Number: TT-10285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1