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

Model Number	105
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility / distributor - during the procedure (mitral valvuloplasty), the physician noticed the balloon ruptured under fluoroscopy.The balloon was successfully removed through the sheath and the product was saved for evaluation.
Additional Manufacturer Narrative
The device was reported as being saved for evaluation, but has not been returned to the manufacturer.The catheter was being used for mitral valvuloplasty, which is an off-label use for this catheter.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 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 3.5 atm, which is more than the labeled rated burst pressure of 2.0 atm, and labeled nomimal pressure of 1.5 atm.

• Brand Name: TYSHAK II CATHETER
• 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: 15462865
• Report Number: 1318694-2022-00011
• Device Sequence Number: 12481070
• Product Code: LIT
• UDI-Device Identifier: 04046964339257
• UDI-Public: 04046964339257
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 105
• Device Catalogue Number: PDC532
• Device Lot Number: TT-14743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2019
• 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
• Patient Sex: Unknown