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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Cardiac Tamponade (2226)
Event Date 09/23/2014
Event Type  Injury  
Manufacturer Narrative

The comparative catheter was pulled and tested for rbp. The device was taken up to rbp (3. 5 atm) with no issue. It was then over inflated to 6. 5 atm at which point the balloon burst. Numed can not confirm if an inflation device with pressure gauge was used, or what pressure the balloon was inflated to, due to lack of information. Numed can not confirm this complaint.

 
Event Description

As reported by hospital on medwatch report: "during balloon dilation of the pulmonary valve the balloon ruptured causing a tear in the main pulmonary artery. 7 week old female with a diagnosis of pulmonary valve stenosis. Patient was scheduled for an elective percutaneous balloon dilation of her pulmonary valve in the cardiac catheterization lab on (b)(6) 2014. In order to perform a balloon dilation, the sheath in the right femoral vein was up-sized from a 4-french to a 5-french. During balloon dilation of the pulmonary valve the balloon burst. The patient became bradycardic and full cardiac resuscitation including cardiac code was begun. The surgical team opened her chest and found a tear in the anterior wall of the main pulmonary artery directly above the pulmonary valve annulus. The team was able to gain control of the bleeding and successfully repair the torn artery. The patient resumed spontaneous sinus rhythm with good blood pressure. The patient was transported to the pediatric icu. ".

 
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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
melissa thomas
2880 main street
hopkinton, NY 12965
MDR Report Key6567697
MDR Text Key75184187
Report Number1318694-2017-00011
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK003052
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 05/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date12/31/2018
Device MODEL Number105
Device Catalogue NumberSO008
Device LOT NumberTT-9600
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/06/2013
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: 05/15/2017 Patient Sequence Number: 1
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