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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 Off-Label Use (1494)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/22/2021
Event Type  Injury  
Manufacturer Narrative
This report was received from numed's foreign distributor in (b)(6). It was sent to them from tga, as it was reported to the regulatory body. The reporter is marked as confidential so the distributor is unable to follow up with the facility to obtain more information. There is very little information given within the report from the tga. A review of the device history record was performed and no issues were found. All devices within the lot met all requirements for release and distribution. There have been no other complaints associated with this lot number. A review of the balloon material used shows there are no other complaints associated with the balloon material used to manufacture the balloons used on this lot of catheters. It was noted in the tga report that this device was being used for aortic valvuloplasty which is an off-label use. This device is only approved for use in pulmonary valvuloplasty. It is unknown as to what pressure this balloon catheter was taken to and what pressure the balloon burst at. A comparative catheter was tested. This catheter was the same catalog number, but a different lot number. The balloon was immersed in a body temperature water bath and inflated until it failed. The comparative catheter did not burst until 3. 5 atm, which is more than the labeled rated burst pressure of 2 atm.
 
Event Description
As per the report sent to numed from their foreign distributor who received it from tga - following second inflation for aortic valvuloplasty, balloon burst and broke into 2 pieces inside the patient, which needed to be retrieved individually.
 
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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 Key12894448
MDR Text Key281902205
Report Number1318694-2021-00012
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K003052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Type of Report Initial
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number105
Device Catalogue NumberPDC533
Device Lot NumberTT-16832
Was Device Available for Evaluation? No
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/30/2021 Patient Sequence Number: 1
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