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

Model Number	105
Medical Device Problem Codes	Break (1069); Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2022
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1318694-2022-00004
• Device Sequence Number: 4776118
• Product Code: LIT
• UDI-Device Identifier: 04046964339431
• UDI-Public: 04046964339431
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K003052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 105
• Device Catalogue Number: PDC541
• Device Lot Number: TT-16040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Unknown