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

Model Number	105
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned for evaluation.Sample of the same catalog number tested for rbp.Device performed according to specifications.The labeled rbp for this device is 2.0 atm.The device burst at 3.0 atm.According to the report, it is unknown as to what pressure the balloon was taken to and what pressure it burst at.The device was being used off-label for aortic stenosis.It is only cleared for pulmonary valvuloplasty.
Event or Problem Description
As per the report received from the distributor: "balloon burst prior to full inflation, tear was circumferential (possibly some longitudinal tear also).While attempting to pull balloon out of the body over the wire, as the ruptured balloon got near the sheath, the balloon clamped down onto the wire.With continued pulling, balloon stretched tightly onto the wire, then shaft broke.Approx 2/3 of balloon came out through the sheath, remainder of the balloon was stuck on the wire, near the sheath.There was a thin layer of balloon shaft stuck on the wire (circumferentially) that prevented physician from advancing anything over the wire.Physician used a scalpel to scrape this thin layer of balloon shaft off the wire.Physician included some of the scraped material in the plastic package with balloon pieces.Physician exchanged the 10 fr sheath for a 14 french short sheath, and advanced a 10mm snare over the wire, past the balloon and to end of the wire (which was now in the right atrium).Physician tightened the snare onto the wire, then pulled everything into the 14 fr sheath (a 14 fr sheath was used to make sure sheath was large enough to assure all balloon fragments would pull safely into the sheath).The physician was using the balloon for an aortic stenosis.An inflation device with pressure gauge was used.It is unknown at what atm balloon burst, it was prior to full inflation.The 10 fr sheath used was a terumo.There was nothing unusual about patient anatomy.A nucleus-x was used to complete procedure.Patient was fine post procedure.".

• Brand Name: TYSHAK II CATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6156116
• Report Number: 1318694-2016-00011
• Device Sequence Number: 19048841
• Product Code: DQY
• UDI-Device Identifier: 04046964339394
• UDI-Public: 04046964339394
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2016

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: 09/30/2017
• Device Model Number: 105
• Device Catalogue Number: PDC539
• Device Lot Number: TT-8574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2016
• Initial Report FDA Received Date: 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1