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HI-TORQUE FLOPPY II Adverse Event — Malfunction (MDR MW1011544)

HI-TORQUE FLOPPY II Adverse Event — Malfunction (MDR MW1011544) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HI-TORQUE FLOPPY II; Generic name: GUIDEWIRE/MICROGLIDE COATING; Manufacturer: GUIDANT ADVANCED CARDIOVASCULAR SYSTEM.

DeviceHI-TORQUE FLOPPY II
Generic nameGUIDEWIRE/MICROGLIDE COATING
ManufacturerGUIDANT ADVANCED CARDIOVASCULAR SYSTEM
Report numberMW1011544
Event typeMalfunction
Product problemY
Date received1997-06-24
NarrativeDURING ANGIOPLASTY/STENT PROCEDURE THE TIP OF THE WIRE (RADIO-OPAQUE #1) BROKE OFF IN THE LEFT CIRCUMFLEX CORONARY ARTERY, DISTAL END. VISUAL UNDER FLUOROSCOPY. NO RETRIEVAL ATTEMPT WAS MADE. PT STABLE. PROCEDURE WAS SUCCESSFULLY COMPLETED. RADIO-OPAQUE TIP IS 2 CM LONG.
SourceopenFDA MAUDE (device adverse events)

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