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	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned for investigation.A comparative catheter of the same catalog number was pulled and tested for rated burst pressure.The labeled rated burst pressure for this catheter is 2.0 atm.The device was taken to 2.0 in a body temperature water bath and did not fail.It was then taken up in pressure until burst occured.It did not burst until 3.5 atm.This catheter is only indicated for pulmonary valvuloplasty.It was being used off-label for aortic valvuloplasty.It is also unknown whether an inflation device with pressure gauge was being used to monitor the pressure, as specified in the instructions for use.It is also unknown as to what pressure the catheter was taken to when the burst occured.
Event or Problem Description
As per the medwatch report received from the fda/user facility: "during pre-dilatation the balloon ruptured and was removed but it had separated from the inner sheath." updated report from bis "in an email from the account: the catheter was used for aortic valvuloplasty.There were no notes about an inflation device being used.There was no mention of any pressure at the time of rupture.A 16fr gore dry-seal sheath was used.The catheter shaft was not kinked.There is a mention of steep horizontal aortic angle in excess of 60 degrees.There is mention of heavy valve calcification.Condition of the patient was stable.Once defective balloon was removed a 29 mm evolut pro core valve was loaded into the delivery catheter.".

• 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: 6826590
• Report Number: 1318694-2017-00024
• Device Sequence Number: 1511486
• Product Code: LIT
• UDI-Device Identifier: 04046964339219
• UDI-Public: 04046964339219
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,other,user facili
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

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: 07/31/2021
• Device Model Number: 105
• Device Catalogue Number: PDC530
• Device Lot Number: TT-11961
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1