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 Information (3190)

Event Date 07/07/2018

Event Type  malfunction  

Manufacturer Narrative

The balloon burst was confirmed. Two comparative catheters from different lots were pulled and tested for rated burst pressure. The labeled rbp for this device is 2. 0 atm. The first comparative catheter was inflated until failure. The device was taken to rbp (2. 0 atms) with no issues. It was then over inflated to 4. 0 atms, which is double the rbp, where it burst longitudinally. The second comparative catheter was also inflated until failure. The device was taken to rbp (2. 0 atms) with no issues. It was then over inflated to 3. 5 atms, which is greater than the rbp, where it burst longitudinally. The user facility stated they used a 50cc syringe to inflate the balloon. They did not use an inflation device with pressure gauge to inflate this balloon as is recommended in the instructions for use. Due to them not using an inflation device with pressure gauge, it is unknown as to what pressure they took the balloon to. It is likely the balloon burst due to over inflation.

Event Description

A 50cc syringe was used to inflate the balloon during procedure, but the balloon ruptured upon 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, ontario K6J 1 G3; CA K6J 1G3
• Manufacturer Contact: melissa thomas ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 7741960
• MDR Text Key: 115918809
• Report Number: 9618000-2018-00004
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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

• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 105
• Device Catalogue Number: PDC536
• Device Lot Number: TH-33273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial