• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUMED, INC. TYSHAK II CATHETER PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NUMED, INC. TYSHAK II CATHETER PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER Back to Search Results
Model Number 105
Device Problems Degraded (1153); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/10/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to numed for review, the complaint could not be confirmed. The user facility would not release the product. This device was not used on a patient. According to the user facility, the balloon ruptured during preparation. A review of the device history records was performed and no issues were noted. There are no other complaints associated with this catheter lot number. A review of the balloon material used shows there are no other complaints associated with the balloon material that was used to manufacture the balloons. 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 not used during the preparation process. A syringe was used which does not allow you to monitor pressure being added to the balloon, so it is unknown as to what pressure the balloon was taken to, and what pressure the balloon burst. A comparative catheter was pulled and tested for rated burst pressure. It was the same catalog number/size as the complaint catheter, but was from a different lot number. The balloon was immersed in a body temperature bath and inflated until it burst. The catheter did not burst until 3. 5 atm, which is well above the labeled rated burst pressure of 2. 0 atm.
 
Event Description
As reported to numed from distributor (b)(6) - upon positive preparation of the balloon dilatation catheter outside the patient's body the event reporter stated the balloon "disintegrated" with around 22ml of solution in the balloon. The balloon ruptured. No patient harm. Update (b)(6) 2020 from (b)(6) - in a conversation with the account: used a 60cc syringe with a 3 to 1 saline to contrast ratio and placed approximately 21 to 22 ml of solution into the balloon during positive preparation. The balloon ruptured / disintegrated. No guidewire was utilized during preparation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTYSHAK II CATHETER
Type of DevicePERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
Manufacturer (Section D)
NUMED, INC.
2880 main street
hopkinton, ny
Manufacturer (Section G)
NUMED, INC.
2880 main street
hopkinton, ny
Manufacturer Contact
nichelle laflesh
2880 main street
hopkinton, ny 
3284491
MDR Report Key10355939
MDR Text Key203494869
Report Number1318694-2020-00007
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 Other Health Care Professional
Type of Report Initial
Report Date 08/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number105
Device Catalogue NumberPDC540
Device Lot NumberTT-156678
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-