ROTABLATOR GUIDE WIRE Adverse Event — Malfunction (MDR MW1011545)

Name: ROTABLATOR GUIDE WIRE Adverse Event — Malfunction (MDR MW1011545)
Creator: DeviceEvents

ROTABLATOR GUIDE WIRE Adverse Event — Malfunction (MDR MW1011545) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ROTABLATOR GUIDE WIRE; Generic name: FLOPPY ROTAWIRE; Manufacturer: HEART TECHNOLOGY, INC..

Device	ROTABLATOR GUIDE WIRE
Generic name	FLOPPY ROTAWIRE
Manufacturer	HEART TECHNOLOGY, INC.
Report number	MW1011545
Event type	Malfunction
Product problem	Y
Date received	1997-06-24
Narrative	ROTO FLOPPY WIRE BROKE OFF OUTSIDE OF BODY. THIS COULD HAVE BEEN A LIFE-THREATENING EVENT IF THE WIRE BROKE OFF INTO THE PT. THE TIP OF THE WIRE BECAME DETACHED. ALSO THE ROTO LINK SYSTEM BECAME DETACHED FROM THE MOTOR DRIVE UNIT DURING ABLATION PROCEDURE AFTER INSERTED INTO THE BODY. PRODUCT WAS ATTACHED PROPERLY TO MOTOR DRIVE UNIT. ALSO WHEN ATTEMPTING TO DYNA-GLIDE OUT OF THE PT WAS UNABLE TO
Source	openFDA MAUDE (device adverse events)

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