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

Model Number	105
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Balloon burst.As per the information provided by the u.S.Distributor, (b)(6), who in turn received an email from the user facility that stated." dr.(b)(6) had to snare out one of your wedge catheters last week.The balloon rupture and broke apart.".
Additional Manufacturer Narrative
The catheter and guidewire were returned in a biohazard bag.The catheter is bloody.There is a lateral tear at the center of the balloon.The distal portion of the balloon is detached.A section of the inner tubing is also detached.This section has been stretched over the guidewire.It could not be removed.The catheter was being used for aortic valvuloplasty, which is an off-label use for this catheter.The pressure the catheter was taken to before failure is unknown heavily calcified aortic valves increase the likelihood of circumferential balloon bursts.The fact that the procedure was completed with a 22 x 4 bard atlas gold (rbp 14 atm) seems to indicate that a higher pressure balloon was required to safely dilate the valve.The detachment was likely caused by attempting to pull the distal end of the balloon back through the introducer.The condition of the inner tubing is consistent with excessive force being applied to the catheter.There is a precaution in the ifu that states: "if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction." 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 catalog number, using the same balloon material, but 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.
Additional Manufacturer Narrative
The catheter and guidewire were returned in a biohazard bag.The catheter is bloody.There is a lateral tear at the center of the balloon.The distal portion of the balloon is detached.A section of the inner tubing is also detached.This section has been stretched over the guidewire.It could not be removed.The catheter was being used for aortic valvuloplasty, which is an off-label use for this catheter.The pressure the catheter was taken to before failure is unknown heavily calcified aortic valves increase the likelihood of circumferential balloon bursts.The fact that the procedure was completed with a 22 x 4 bard atlas gold (rbp 14 atm) seems to indicate that a higher pressure balloon was required to safely dilate the valve.The detachment was likely caused by attempting to pull the distal end of the balloon back through the introducer.The condition of the inner tubing is consistent with excessive force being applied to the catheter.There is a precaution in the ifu that states: "if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction." 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 catalog number, using the same balloon material, but 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
Balloon burst.As per the information provided by the u.S.Distributor, (b)(4), who in turn received an email from the user facility that stated." dr.(b)(6) had to snare out one of your wedge catheters last week.The balloon rupture and broke apart.".

• 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: 13452437
• Report Number: 1318694-2022-00002
• Device Sequence Number: 20050372
• Product Code: LIT
• UDI-Device Identifier: 04046964339370
• UDI-Public: 04046964339370
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

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: 09/30/2026
• Device Model Number: 105
• Device Catalogue Number: PDC538
• Device Lot Number: TT-17355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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: Required Intervention
• Patient Sex: Unknown