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U.S. Department of Health and Human Services

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

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NUMED, 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 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
The device was being used off label for an unapproved indication. This catheter is only indicated for percutaneous valvuloplasty of the pulmonary valve. This device was being used for aortic valvuloplasty. An inflation device with pressure gauge was not used as specified in the instructions for use, so it is unknown as to what pressure this catheter was taken to. A comparative catheter was pulled and tested for rated burst pressure. This device was the same catalog number as the complaint catheter. The labeled rbp for the device is 2. 0 atm. The comparative catheter was immersed in a body temperature bath and inflated until it failed. The catheter did not burst until 3. 0 atm, which is above the labeled rbp.
 
Event Description
As per the report received from bis: "the product was used on the aortic valve. The balloon ruptured. A hand syringe inflation was used. ".
 
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Brand NameTYSHAK II CATHETER
Type of DevicePERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
Manufacturer (Section D)
NUMED, INC.
2880 main street
hopkinton NY 12965
Manufacturer (Section G)
NUMED, INC.
2880 main street
hopkinton NY 12965
Manufacturer Contact
nichelle laflesh
2880 main street
hopkinton, NY 12965
3153284491
MDR Report Key7201185
MDR Text Key97893223
Report Number1318694-2018-00001
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation
Type of Report Initial
Report Date 01/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Model Number105
Device Catalogue NumberPDC534
Device Lot NumberTT-10285
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2014
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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