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

Model Number	105
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to numed for review so the balloon burst cannot be confirmed.A review of the device history records was performed and no issues were noted.There are 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 lot number used.This device was being used off-label for an unapproved use.This device is only approved for percutaneous transluminal valvuloplasty of the pulmonary valve.It was being used in the aortic valve.As per the instructions for use, an inflation device with pressure gauge should be used on the device to monitor pressure.In this case, an inflation device with pressure gauge was not used.A syringe was used which does not allow you to monitor the pressure being added to the balloon, so it is unknown as to what pressure the balloon was taken to, and what pressure the balloon burst.In the report from the user facility, they state that they believe the balloon burst was caused by either a "sharp calcific edge from the aortic valve and/or being inflated adjacent to the crimped undeployed valve cage loaded on its delivery system".A comparative catheter was pulled and tested for rated burst pressure.It was the same catalog number / size as the complaint catheter, but a different lot number.The balloon was immersed in a body temperature water bath and inflated until it burst.The catheter did not burst until 3.5 atm, which is well above the labeled rated burst pressure of 2.0 atm.
Event or Problem Description
Per the report from the medwatch form / distributor - the balloon was hand inflated nominal size (18mm) using a vac-lok locking syringe.After reaching its nominal size using fluoroscopy, the balloon ruptured.Physician immediately pulled a negative pressure on the vac-lok's plunger and locked it.Blood observed returning from the balloon port (which is supposed to be a closed system).The balloon was withdrawn from the patient with vac-lok plunger locked on negative.There were ekg changes after balloon rupturing.Concern if there may have been some air/micro-bubbles dispursed during the balloon rupturing.The balloon ruptured from either a sharp calcific edge from the aortic valve and/or being inflated adjacent to the "crimped" undeployed valve cage loaded on its delivery system may have ruptured the balloon.Once removed it was confirmed the balloon ruptured.Procedure completed.No harm to patient.4/24/2020: in a conversation with the bis sales specialist and the account: a 9fr sheath was used.The catheter shaft was not kinked.The balloon was removed and replaced with a marker pigtail.The removed balloon was intact, no missing parts.

• Brand Name: TYSHAK II CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton, ny
• MDR Report Key: 10043618
• Report Number: 1318694-2020-00006
• Device Sequence Number: 3072542
• Product Code: LIT
• UDI-Device Identifier: 04046964339202
• UDI-Public: 04046964339202
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K003052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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: No Information
• Device Expiration Date: 12/31/2024
• Device Model Number: 105
• Device Catalogue Number: PDC529
• Device Lot Number: TT-15512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1