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

Model Number 105

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to numed for review.The arrived intact and all components were accounted for.The catheter has traces of blood inside the tubing.A longitudinal balloon burst is confirmed.There are no kinks in the tubing.The report states that the balloon burst at the rbp of 2.0 atm.A dvd was returned with the device and was reviewed.It looks like the balloon performed as it should, but patient anatomy may have contributed to the balloon burst.Two catheters were pulled and tested for rbp.Both of these catheters were the same catalog number as the complaint catheter, but have different lot numbers.A 0.035" guidewire was inserted in each catheter.The catheter balloons were then inflated with an inflation device with pressure gauge up to the rbp of 2.0 atm.No issues were noted.The catheter balloons were then inflated beyond labeled rbp until they burst.One balloon burst at 4.0 atm and one burst at 3.8 atm, which is well above the labeled rated burst pressure of 2.0 atm.Both were clean longitudinal bursts.A component review of the balloon material used on the complaint device was performed.A total of 328 balloons have been made and issued to devices using the same balloon material as the complaint catheter.No other complaints have been received on this balloon material lot number.

Event Description

According to the report received from the distributor - "balloon rupture during inflation.".

• Brand Name: TYSHAK II CATHETER
• 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, K6J 1 G3; CA K6J 1G3
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 8869184
• MDR Text Key: 168209119
• Report Number: 9618000-2019-00007
• 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,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 105
• Device Catalogue Number: PDC533
• Device Lot Number: TH-32643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 15