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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 Burst Container or Vessel (1074)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 07/12/2019
Event Type  Death  
Manufacturer Narrative
The catheter was returned to numed for review. A longitudinal tear was confirmed in the balloon. The cause of the balloon burst could not be identified through microscopic inspection. The device history records were reviewed and no issues were identified. All devices that were distributed met the criteria for release and passed all inspection processes and procedures. There have no other complaints with this catheter lot. A review of the balloon tubing used to manufacture this device was also performed. There were no other associated complaints with this lot of balloon tubing. Tyshak ii catheters are leak tested in final qc at labeled rated burst pressure. A comparative device was pulled and tested for rated burst pressure. This device was the same catalog number as the complaint device, 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 burst at 4. 0 atm, which is double the labeled rated burst pressure of 2. 0 atm. It was a longitudinal burst. According to the report from the hospital, the device was being used off label for an unapproved indication; aortic valvuloplasty. This catheter is only indicated for pulmonary valvuloplasty. The report from the hospital also states that the physician believed the rupture to be caused by the heavy calcium on the patient's valve which poked a hole in the balloon. The patient coded during the procedure and did not survive. Physician stated that the patient did not code as a result of the rupture. It is unknown if an inflation device with pressure gauge was used to monitor the inflation pressure during the procedure as specified in the instructions for use.
 
Event Description
Medwatch report received from distributor (b)(4), who received it from the fda - valvuloplasty balloon was inflated and then burst. It is believed that the balloon ruptured due to the heavy calcium on the patient's valve which poked a hole in the plastic of the balloon. Information from the account that was sent to (b)(4) as a follow-up - "it is unknown if an inflation device with pressure gauge was used. The patient condition post procedure: patient coded during the procedure and did not survive. Physician said that patient did not code as a result of the rupture. It was aortic. The type and size of guidewire used is unknown and it is unknown if the shaft was kinked. ".
 
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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 Key9123111
MDR Text Key160294388
Report Number1318694-2019-00019
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,other,user facili
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number105
Device Catalogue NumberPDC529
Device Lot NumberTT-13460
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2017
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: 09/26/2019 Patient Sequence Number: 1
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