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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 Stenosis (2263)
Event Date 12/30/2019
Event Type  malfunction  
Manufacturer Narrative
The device returned to numed for evaluation. A longitudinal tear is confirmed. The balloon was examined at 10x magnification. Nothing was observed that would have caused the balloon burst. This device was being used off-label for an unapproved use. This device is only approved for percutaneous transluminal valvuloplasty of the pulmonary valve. It was being used for iliac stenosis. 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 atm, which is well above the labeled rated burst pressure of 2. 0 atm, and nominal pressure of 1. 5 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 used, however it was unknown as to what pressure the catheter was taken to and what pressure it burst at. A review of the device history record was performed and no issues were noted. There are 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 lot.
 
Event Description
As per the report from the user facility / distributor - balloon ruptured. An inflation device was used with a 20cc syringe attached to the sideport. A 10fr terumo introducer sheath was used. The catheter shaft was not kinked. There was nothing unusual about the patient anatomy. The patient was stable post procedure. Update - 1/13/2020 - in an email from the account: the indication the physician was using the balloon for was iliac stenosis. An xxl esophageal balloon was used to complete the procedure. Update - 1/15/2020 - in an email from the account: an inflation service with pressure gauge was used. The guidewire size and type is unknown.
 
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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 Key9649315
MDR Text Key190804110
Report Number1318694-2020-00003
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 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number105
Device Catalogue NumberPDC534
Device Lot NumberTT-14882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2019
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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