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

Model Number	107
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint catheter was received.The catheter is bloody, so numed questioned whether or not it was used on a patient.Initially the report had it as being ruptured during pre-dilatation testing.It was confirmed that the catheter was in the patient when the physician partially inflated the balloon and it burst.There is a longitudinal tear in the balloon.The cause of the balloon burst could not be identified through microscopic inspection.A comparative catheter was pulled and tested for rated burst pressure.It was the same size as the complaint catheter, but a different lot number.The balloon was immersed in a body temperature bath and inflated until failure.The balloon burst at 10 atm, which is more than the labeled rated burst pressure of 6 atm.All catheters are leak tested at final qc.The device history records were reviewed and all catheters met all acceptance criteria prior to release.No issues were found with the dhr review.This catheter was being used off label for aortic angioplasty.This device is only approved for pediatric percutaneous transluminal valvuloplasty.
Event or Problem Description
As per the report from the user facility / distributor - pre-dilatation balloon test with contrast burst the balloon.The indication the physician was using the balloon for: coarctation of the aorta / angioplasty.An inflation device with pressure gauge was used.A 4 fr introducer sheath was used.The catheter shaft was not kinked.A 6mm tyshak mini was used to complete the procedure without incident.The balloon ruptured longitudinally and below nominal: 1-2 rbp.

• Brand Name: TYSHAK MINI
• Common Device Name: PEDIATRIC PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 9476551
• Report Number: 1318694-2019-00027
• Device Sequence Number: 19367930
• Product Code: DQY
• UDI-Device Identifier: 04046964339653
• UDI-Public: 04046964339653
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K003276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: 02/28/2022
• Device Model Number: 107
• Device Catalogue Number: PDC401
• Device Lot Number: TYM-1686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1