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U.S. Department of Health and Human Services

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

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NUMED, INC. TYSHAK II PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY 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 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
The catheter was returned and is clean. It was not used on a patient. A longitudinal tear in the balloon was confirmed. The cause could not be identified through microscopic inspection. A comparative catheter was tested for rated burst pressure. It was the same catalog number / size as the complaint catheter, but a different lot number. The balloon was immersed in a body temperature water bath and inflated in 0. 5 atm increments until failure. The balloon tore in a longitudinal manner at 3. 5 atm, which is well above the labeled rated burst pressure of 2. 0 atm. As per the instructions for use, an inflation device with pressure gauge should be used on the device to monitor pressure. In this case, an inflation device with pressure gauge was not used, making it impossible to determine how much pressure was applied to the balloon before it burst.
 
Event Description
As per the report from the user facility / distributor - during positive balloon preparation as indicated in the ifu, the physician filled the balloon with contrast/saline mixture (ration unknown) to a "soft" dilated state with either a 30 or 60cc syringe. Upon "pullback" to expel air, the physician noted that the balloon burst. The nature of this burst was not known. The catheter shaft was not kinked. A 611937 pdc537 was used to complete the procedure. It is unknown at what pressure the balloon ruptured.
 
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Brand NameTYSHAK II
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 Key9449891
MDR Text Key206821787
Report Number1318694-2019-00025
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 12/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number105
Device Catalogue NumberPDC532
Device Lot NumberTT-15152
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2019
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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