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U.S. Department of Health and Human Services

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

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NUMED CANADA, INC. TYSHAK II CATHETER PERCUTANEOUS VALVULOPLASTY CATHETER Back to Search Results
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.
 
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Brand NameTYSHAK II CATHETER
Type of DevicePERCUTANEOUS 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 Key7400101
MDR Text Key104526836
Report Number9618000-2018-00002
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K003052
Number of Events Reported1
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 Received04/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number105
Device Catalogue NumberPDC538
Device Lot NumberTH-30790
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/08/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/19/2017
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
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