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

Model Number 105

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The catheter was returned with all components accounted for.The catheter is extremely dirty.It is unknown as to whether or not this was the first use of the device.A longitudinal tear of the balloon was confirmed.The user facility states that it burst at the labeled rated burst pressure of 2 atm.Two comparative catheters were pulled and tested for rated burst pressure.They were the same catalog number as the returned catheter.The first catheter was taken up to the labeled rated burst pressure of 2 atm with no issues.The balloon was then taken to beyond the rated burst pressure and did not burst until 3.5 atm.It was a clean longitudinal burst.The second catheter was also taken up to the labeled rated burst pressure of 2 atm with no issues.The balloon was then taken to beyond the rated burst pressure and did not burst until 4.0 atm.It is unknown as to what caused the balloon burst.

Event Description

The issue was reported to numed as a "rupture of balloon.".

• Brand Name: TYSHAK II
• Type of Device: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED CANADA, INC.; 45 second street west; cornwall, ontario K6J 1 G3; CA K6J 1G3
• Manufacturer (Section G): NUMED CANADA, INC.; 45 second street west; cornwall, ontario K6J 1 G3; CA K6J 1G3
• Manufacturer Contact: nichelle laflesh ; 45 second street west; cornwall, ontario K6J 1-G3 ; CA K6J 1G3
• MDR Report Key: 7985396
• MDR Text Key: 124674564
• Report Number: 9618000-2018-00005
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K003052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 105
• Device Catalogue Number: PDC532
• Device Lot Number: TH-31298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 40