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

Model Number	105
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device returned to numed for evaluation.A longitudinal tear is confirmed.The balloon was examined at 10x magnification.Nothing was observed that would have caused the balloon burst.This device was being used off-label for an unapproved use.This device is only approved for percutaneous transluminal valvuloplasty of the pulmonary valve.It was being used for iliac stenosis.A comparative catheter was tested for rated burst pressure.It was the same catalog number / size as the complaint catheter, but a different lot number.The balloon was immersed in a body temperature water bath and inflated in 0.5 atm increments until failure.The balloon tore in a longitudinal manner at 3 atm, which is well above the labeled rated burst pressure of 2.0 atm, and nominal pressure of 1.5 atm.As per the instructions for use, an inflation device with pressure gauge should be used on the device to monitor pressure.In this case, an inflation device with pressure gauge was used, however it was unknown as to what pressure the catheter was taken to and what pressure it burst at.A review of the device history record was performed and no issues were noted.There are no other complaints associated with this lot number.A review of the balloon material used shows there are no other complaints associated with the balloon material lot.
Event or Problem Description
As per the report from the user facility / distributor - balloon ruptured.An inflation device was used with a 20cc syringe attached to the sideport.A 10fr terumo introducer sheath was used.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.The patient was stable post procedure.Update - 1/13/2020 - in an email from the account: the indication the physician was using the balloon for was iliac stenosis.An xxl esophageal balloon was used to complete the procedure.Update - 1/15/2020 - in an email from the account: an inflation service with pressure gauge was used.The guidewire size and type is unknown.

• 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: 9649315
• Report Number: 1318694-2020-00003
• Device Sequence Number: 2778374
• Product Code: LIT
• UDI-Device Identifier: 04046964339295
• UDI-Public: 04046964339295
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/30/2020

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: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 105
• Device Catalogue Number: PDC534
• Device Lot Number: TT-14882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 81