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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 Problems Break (1069); Off-Label Use (1494)
Patient Problem Insufficient Information (4580)
Event Date 03/19/2022
Event Type  Death  
Manufacturer Narrative
The catheter was not returned for review. The physician provided additional information that stated that the pre-existing conditions contributed to the death and he did not attribute it to the balloon burst. The catheter was being used for aortic valvuloplasty, which is an off-label use for this catheter. An inflation device with pressure gauge was not used. The pressure reached before failure is unknown. There is a warning in the instructions for use that states: "caution: do not exceed rbp. An inflation device with pressure gauge is recommended to monitor pressure. Pressure in excess of the rbp can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath. " 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 component lot number shows there are no other complaints associated with the balloon used on this lot of catheters. A comparative catheter was tested. This catheter was the same balloon diameter, was manufactured using the same balloon material, but had 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. 0 atm, which is more than the labeled rated burst pressure of 2. 0 atm, and labeled nominal pressure of 1. 5 atm.
 
Event Description
As reported to numed by the distributor /user facility - physician was using the tyshak balloon during a procedure and the balloon ruptured. This patient expired during the procedure. Physician believes the death is unlikely related to the balloon rupture and attributable more to the pre-existing conditions in this patient.
 
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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 Key14105818
MDR Text Key289220714
Report Number1318694-2022-00004
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 User Facility,Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number105
Device Catalogue NumberPDC541
Device Lot NumberTT-16040
Was Device Available for Evaluation? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2022 Patient Sequence Number: 1
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