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U.S. Department of Health and Human Services

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

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NUMED CANADA, INC. TYSHAK II CATHETER PTV CATHETER Back to Search Results
Model Number 105
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to numed canada, inc. And the balloon burst was confirmed. A review of the device history record was performed and no issues were noted. There are no other complaints associated with this lot number. A review of the balloon material used showed there were no other complaints associated with this balloon material lot number used. Two comparative catheters from different lots were pulled and tested for rated burst pressure. The labeled rbp for this device is 3. 0 atm. The first comparative catheter was inflated until failure. The device was taken to rbp (3. 0 atms) with no issues. It was then over inflated to 4. 5 atms, which is greater than the rbp, where it burst longitudinally. The second comparative catheter was also inflated until failure. The device was taken to rbp (3. 0 atms) with no issues. It was then over inflated to 5. 0 atms, which is also greater than the rbp, where it burst longitudinally.
 
Event Description
As per the incident report from swissmedic - "balloon rupture, horizontal, at 2. 5". Serious consequences or possible serious consequences for patient - "no. ".
 
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Brand NameTYSHAK II CATHETER
Type of DevicePTV 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 Key10296524
MDR Text Key204959561
Report Number9618000-2020-00001
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K003052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 07/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number105
Device Catalogue NumberSO036
Device Lot NumberTH-35391
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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