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

Model Number 105

Device Problem Off-Label Use (1494)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

This report was received from numed's foreign distributor in (b)(6). It was sent to them from tga, as it was reported to the regulatory body. The reporter is marked as confidential so the distributor is unable to follow up with the facility to obtain more information. There is very little information given within the report from the tga. A review of the device history record was performed and no issues were found. All devices within the lot met all requirements for release and distribution. There have been 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 used to manufacture the balloons used on this lot of catheters. It was noted in the tga report that this device was being used for aortic valvuloplasty which is an off-label use. This device is only approved for use in pulmonary valvuloplasty. It is unknown as to what pressure this balloon catheter was taken to and what pressure the balloon burst at. A comparative catheter was tested. This catheter was the same catalog number, but a different lot number. The balloon was immersed in a body temperature water bath and inflated until it failed. The comparative catheter did not burst until 3. 5 atm, which is more than the labeled rated burst pressure of 2 atm.

Event Description

As per the report sent to numed from their foreign distributor who received it from tga - following second inflation for aortic valvuloplasty, balloon burst and broke into 2 pieces inside the patient, which needed to be retrieved individually.

• Brand Name: TYSHAK II
• Type of Device: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 12894448
• MDR Text Key: 281902205
• Report Number: 1318694-2021-00012
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K003052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 105
• Device Catalogue Number: PDC533
• Device Lot Number: TT-16832
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/30/2021 Patient Sequence Number: 1