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

Model Number 105

Device Problems Leak/Splash (1354); Difficult to Open or Close (2921)

Patient Problem No Code Available (3191)

Event Date 02/24/2018

Event Type  Injury  

Manufacturer Narrative

This device was being used off label to place a stent. There is a specific warning in the instructions for use that states - "the catheter is not intended for use with stents. " this catheter is only approved for percutaneous transluminal valvuloplasty. Both the catheter and the stent were being used off label for unapproved indications. It states in the report from the physician that he over inflated the balloon to 3. 0 atm. The labeled rbp for this size is 2. 0 atm. A review of the complaint device shows that a pinhole is located in the balloon. The pin hole was most likely caused by the crimping of the stent on the balloon. This is what caused the balloon to not inflate, which in turn caused the stent not to deploy properly. Two comparative catheters - same model and balloon size were tested for rated burst pressure. One of the comparative catheters was taken to 3. 5 atm before burst, and the other comparative catheter was taken to 4. 0 atm before burst. The off label use, failure to follow instructions, and user error caused this adverse event and product malfunction.

Event Description

As per the report from the user facility and distributor - the tyshak ii catheter was being used to place a stent - svc stenting for sinus venous asd, and the balloon had a leak at the upper end. While the stent was being deployed the upper portion of the balloon started leaking and the stent was not opening. The lower portion deployed well. The patient had to be taken for emergency open heart surgery for stent removal and sv asd repair.

• Brand Name: TYSHAK II CATHETER
• Type of Device: PERCUTANEOUS VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED CANADA, INC.; 45 second street west; cornwall, 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 ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 7400101
• MDR Text Key: 104526836
• Report Number: 9618000-2018-00002
• 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

• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 105
• Device Catalogue Number: PDC538
• Device Lot Number: TH-30790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2017
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/05/2018 Patient Sequence Number: 1