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U.S. Department of Health and Human Services

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

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NUMED CANADA, INC. TYSHAK II PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER Back to Search Results
Model Number 105
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2019
Event Type  malfunction  
Manufacturer Narrative
The device returned to numed canada for evaluation. The catheter arrived intact and all components are accounted for. The catheter is very clean with no traces of blood of contrast. A longitudinal burst is confirmed. There are 2 small kinks or bunching with a slight twist of the tubing. One at 22 cm from the tip and the other 24. 5 cm from the tip. 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 aortic valvuloplasty. A review of the device history record was performed and no issues were noted. There are no other complaints associated with this lot number. Two catheters with the same balloon diameter and length were pulled and tested. One of the two is the same catalog number, but different lot number. The other was a different catalog number and lot number. Both of the devices were manufactured using the same balloon tubing lot as the complaint catheter. Both catheters were inflated to the labeled rated burst pressure of 4. 0 atm, with no issues. They were then inflated beyond the rbp until the balloon burst. One burst at 9. 5 atm and the other burst at 9. 7 atm. Both were clean longitudinal bursts. A review of the balloon material used shows that (b)(4) balloons were made and there are no other complaints associated with the balloon material lot.
 
Event Description
As per the report from the distributor - according to the physician the balloon ruptured immediately after inflation and he could not use it. The balloon is also available for return. The patient is stable and another balloon was used to complete the procedure.
 
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Brand NameTYSHAK II
Type of DevicePERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
Manufacturer (Section D)
NUMED CANADA, INC.
45 second street west
cornwall, K6J 1 G3
CA K6J 1G3
Manufacturer (Section G)
NUMED CANADA, INC.
45 second street west
cornwall, K6J 1 G3
CA K6J 1G3
Manufacturer Contact
nichelle laflesh
45 second street west
cornwall, K6J 1-G3
CA   K6J 1G3
MDR Report Key8827502
MDR Text Key216378758
Report Number9618000-2019-00005
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K003052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 07/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number105
Device Catalogue NumberPDC502
Device Lot NumberTH-34512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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