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

Model Number 105

Device Problem Burst Container or Vessel (1074)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 07/12/2019

Event Type  Death  

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 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
• Type of Device: 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: 9123111
• MDR Text Key: 160294388
• Report Number: 1318694-2019-00019
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 105
• Device Catalogue Number: PDC529
• Device Lot Number: TT-13460
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/26/2019 Patient Sequence Number: 1