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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUMED CANADA, INC. Z-MED II CATHETER PTV CATHETER

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NUMED CANADA, INC. Z-MED II CATHETER PTV CATHETER Back to Search Results
Model Number 305
Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2018
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 5. 0 atm. The first comparative catheter was inflated until failure. The device was taken to rbp (5. 0 atms) with no issues. It was then over inflated to 11. 5 atms, which is greater than double the rbp, where it burst longitudinally. The second comparative catheter was also inflated until failure. The device was taken to rbp (5. 0 atms) with no issues. It was then over inflated to 11. 0 atms, which is also greater than double the rbp, where it burst longitudinally. It is unknown what caused the balloon to burst.
 
Event Description
"contract medium flowed out from the balloon when inflating the balloon. The inflation pressure was less than the rated burst pressure. ".
 
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Brand NameZ-MED 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 Key8134599
MDR Text Key129889890
Report Number9618000-2018-00007
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K003052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number305
Device Catalogue NumberPDZ657
Device Lot NumberJZ-19172
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2018
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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