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

Model Number	105
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	07/12/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The catheter was returned to numed for review.A longitudinal tear was confirmed in the balloon.The cause of the balloon burst could not be identified through microscopic inspection.The device history records were reviewed and no issues were identified.All devices that were distributed met the criteria for release and passed all inspection processes and procedures.There have no other complaints with this catheter lot.A review of the balloon tubing used to manufacture this device was also performed.There were no other associated complaints with this lot of balloon tubing.Tyshak ii catheters are leak tested in final qc at labeled rated burst pressure.A comparative device was pulled and tested for rated burst pressure.This device was the same catalog number as the complaint device, but a different lot number.The balloon was immersed in a body temperature water bath and inflated in 0.5 atm increments until failure.The balloon burst at 4.0 atm, which is double the labeled rated burst pressure of 2.0 atm.It was a longitudinal burst.According to the report from the hospital, the device was being used off label for an unapproved indication; aortic valvuloplasty.This catheter is only indicated for pulmonary valvuloplasty.The report from the hospital also states that the physician believed the rupture to be caused by the heavy calcium on the patient's valve which poked a hole in the balloon.The patient coded during the procedure and did not survive.Physician stated that the patient did not code as a result of the rupture.It is unknown if an inflation device with pressure gauge was used to monitor the inflation pressure during the procedure as specified in the instructions for use.
Event or Problem Description
Medwatch report received from distributor (b)(4), who received it from the fda - valvuloplasty balloon was inflated and then burst.It is believed that the balloon ruptured due to the heavy calcium on the patient's valve which poked a hole in the plastic of the balloon.Information from the account that was sent to (b)(4) as a follow-up - "it is unknown if an inflation device with pressure gauge was used.The patient condition post procedure: patient coded during the procedure and did not survive.Physician said that patient did not code as a result of the rupture.It was aortic.The type and size of guidewire used is unknown and it is unknown if the shaft was kinked.".

• Brand Name: TYSHAK II CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 9123111
• Report Number: 1318694-2019-00019
• Device Sequence Number: 2322878
• Product Code: LIT
• UDI-Device Identifier: 04046964339202
• UDI-Public: 04046964339202
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,other,user facili
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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: 12/31/2022
• Device Model Number: 105
• Device Catalogue Number: PDC529
• Device Lot Number: TT-13460
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death