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U.S. Department of Health and Human Services

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

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NUMED CANADA, INC. TYSHAK II PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER Back to Search Results
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. ".
 
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Brand NameTYSHAK II
Type of DevicePERCUTANEOUS 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 Key7985396
MDR Text Key124674564
Report Number9618000-2018-00005
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,user faci
Reporter Occupation
Type of Report Initial
Report Date 10/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number105
Device Catalogue NumberPDC532
Device Lot NumberTH-31298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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