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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 Off-Label Use (1494)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2021
Event Type  Injury  
Manufacturer Narrative
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 material used shows there are no other complaints associated with the balloon material used to manufacture the balloons used on this lot of catheters. The catheter was returned in a biohazard bag. The catheter is bloody. The introducer is still on the catheter. There is a circumferential tear in the balloon. The proximal end of the balloon has been pulled back to the proximal end of the introducer. The distal end of the balloon, which is inverted, is lodged in the distal end of the introducer. The inner tubing is stretched, but intact. The catheter is whole with no pieces missing from the device. The report from the distributor stated that a partial cut down of the femoral vein was performed to locate and remove a distal balloon fragment, however, the device was not missing any pieces when it was returned to numed for investigation. A comparative catheter was pulled and tested for rated burst pressure. The comparative catheter was the same catalog number but a different lot number as the complaint catheter. The balloon was immersed in a body temperature bath and incrementally inflated until it burst. The catheter did not burst until 4. 5 atm, which is well above the labeled rated burst pressure of 2. 0 atm and labeled nominal pressure of 1. 5 atm. This device was being used off label for an unapproved indication. The approved indication is pulmonary valvuloplasty. The device was being used for a static atrial septostomy procedure. It is likely that this led to the balloon burst.
 
Event Description
Per the report from the user facility / distributor - balloon rupture of an 18mm x 5cm tyshak ii balloon inflated to rbp (but not greater than rbp). An inflation device with pressure gauge was used. The indication the physician was using the balloon for was static atrial septostomy. The size and type of introducer sheath being used: 8fr terumo. The rupture was circumferential and the physician could not risk the wire position while on va ecmo, therefore performed a partial cut down of the femoral vein to locate the distal balloon fragment (which had inverted on itself) and removed it. Patient condition post procedure was critical, however not related to the balloon rupture.
 
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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 Key11678262
MDR Text Key245777703
Report Number1318694-2021-00004
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 distributor,user facility
Reporter Occupation
Type of Report Initial
Report Date 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
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-16513
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2020
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: 04/16/2021 Patient Sequence Number: 1
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