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

Model Number	105
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to numed for review, the complaint could not be confirmed.The user facility would not release the product.This device was not used on a patient.According to the user facility, the balloon ruptured during preparation.A review of the device history records was performed and no issues were noted.There are no other complaints associated with this catheter lot number.A review of the balloon material used shows there are no other complaints associated with the balloon material that was used to manufacture the balloons.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 not used during the preparation process.A syringe was used which does not allow you to monitor pressure being added to the balloon, so it is unknown as to what pressure the balloon was taken to, and what pressure the balloon burst.A comparative catheter was pulled and tested for rated burst pressure.It was the same catalog number/size as the complaint catheter, but was from a different lot number.The balloon was immersed in a body temperature bath and inflated until it burst.The catheter did not burst until 3.5 atm, which is well above the labeled rated burst pressure of 2.0 atm.
Event or Problem Description
As reported to numed from distributor (b)(6) - upon positive preparation of the balloon dilatation catheter outside the patient's body the event reporter stated the balloon "disintegrated" with around 22ml of solution in the balloon.The balloon ruptured.No patient harm.Update (b)(6) 2020 from (b)(6) - in a conversation with the account: used a 60cc syringe with a 3 to 1 saline to contrast ratio and placed approximately 21 to 22 ml of solution into the balloon during positive preparation.The balloon ruptured / disintegrated.No guidewire was utilized during preparation.

• Brand Name: TYSHAK II CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton, ny
• MDR Report Key: 10355939
• Report Number: 1318694-2020-00007
• Device Sequence Number: 2767340
• Product Code: LIT
• UDI-Device Identifier: 04046964339417
• UDI-Public: 04046964339417
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2020

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: Other
• Device Expiration Date: 01/31/2025
• Device Model Number: 105
• Device Catalogue Number: PDC540
• Device Lot Number: TT-156678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1