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U.S. Department of Health and Human Services

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

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NUMED CANADA, INC. TYSHAK II CATHETER PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER Back to Search Results
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.
 
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Brand NameTYSHAK II CATHETER
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
melissa thomas
2880 main street
hopkinton, NY 12965
3153284491
MDR Report Key7741960
MDR Text Key115918809
Report Number9618000-2018-00004
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSN
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 08/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number105
Device Catalogue NumberPDC536
Device Lot NumberTH-33273
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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