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

Model Number 105

Device Problems Break (1069); Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2022

Event Type  Death  

Manufacturer Narrative

The catheter was not returned for review.The physician provided additional information that stated that the pre-existing conditions contributed to the death and he did not attribute it to the balloon burst.The catheter was being used for aortic valvuloplasty, which is an off-label use for this catheter.An inflation device with pressure gauge was not used.The pressure reached before failure is unknown.There is a warning in the instructions for use that states: "caution: do not exceed rbp.An inflation device with pressure gauge is recommended to monitor pressure.Pressure in excess of the rbp can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath." 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 component lot number shows there are no other complaints associated with the balloon used on this lot of catheters.A comparative catheter was tested.This catheter was the same balloon diameter, was manufactured using the same balloon material, but had a different lot number.The balloon was immersed in a body temperature water bath and inflated until it failed.The comparative catheter did not burst until 3.0 atm, which is more than the labeled rated burst pressure of 2.0 atm, and labeled nominal pressure of 1.5 atm.

Event Description

As reported to numed by the distributor /user facility - physician was using the tyshak balloon during a procedure and the balloon ruptured.This patient expired during the procedure.Physician believes the death is unlikely related to the balloon rupture and attributable more to the pre-existing conditions in this patient.

• Brand Name: TYSHAK II
• Type of Device: PERCUTANEOUS 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 Key: 14105818
• MDR Text Key: 289220714
• Report Number: 1318694-2022-00004
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 04046964339431
• UDI-Public: 04046964339431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105
• Device Catalogue Number: PDC541
• Device Lot Number: TT-16040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR