FDA Adverse Event Malfunction Summary report: N

Z-MED II-X CATHETER

MDR report key: 7048034 · Received November 21, 2017

Report

Report Number: 1318694-2017-00028
Event Type: Malfunction
Date Received: November 21, 2017
Date of Event: October 20, 2017
Report Date: November 21, 2017
Manufacturer: NUMED, INC.
Product Code: DQY
UDI-DI: 04046964315848
PMA / PMN Number: K022722
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

NUMED NOTIFIED OF THIS MEDWATCH REPORT BY BRAUN INTERVENTIONAL SYSTEMS. BRAUN INTERVENTIONAL SYSTEMS RECEIVED THE REPORT FROM B. BRAUN MEDICAL. B. BRAUN MEDICAL RECEIVED THE REPORT FROM THE FDA. THE MEDWATCH REPORT CONTAINS VERY MINIMAL INFORMATION AND THERE IS NO INFORMATION AS TO WHO THE USER FACILITY/INITIAL REPORTER IS. NUMED IS UNABLE TO EVEN CONFIRM THIS COMPLAINT. BASED ON THE MINIMAL INFORMATION THAT WAS SUPPLIED IN THE USER FACILITY MEDWATCH REPORT, WE CAN DETERMINE THAT THIS DEVICE WAS BEING USED OFF-LABEL. THIS DEVICE IS ONLY APPROVED FOR PULMONARY VALVULOPLASTY AND IN THE REPORT IT STATES THAT IT WAS BEING USED FOR BALLOON AORTIC VALVULOPLASTY. A COMPARISON CATHETER OF THE SAME CATALOG NUMBER WAS PULLED AND TESTED FOR BURST PRESSURE. THE RATED BURST PRESSURE FOR THIS SIZE IS 7 ATM. THE COMPARATIVE CATHETER WAS INFLATED TO RBP WITH NO ISSUES. IT WAS THEN TAKEN ABOVE THE RBP AND DIDN' BURST UNTIL 11 ATM, WHICH IS WELL ABOVE THE LABELED RATED BURST PRESSURE FOR THIS DEVICE.

Description of Event or Problem · 1

MEDWATCH FORM RECEIVED BY BIS FROM FDA - "DURING BALLOON AORTIC VALVULOPLASTY, THE BALLOON INITIALLY INFLATED BUT RUPTURED. AS A RESULT, THIS BALLOON WAS REMOVED AND ANOTHER BALLOON WAS INFLATED SUCCESSFULLY."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
829123	Z-MED II-X CATHETER	PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER	DQY	NUMED, INC.	305X	ZZX-1936	04046964315848

Patients

Seq	Age	Sex	Outcome	Treatment
1