ANGIOSCORE, INC. ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, ANGIOPLASTY, PERIPHERAL
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Model Number 2249-50200 |
Device Problems
Difficult to Insert (1316); Difficult to Remove (1528); Failure to Advance (2524)
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Patient Problems
Atherosclerosis (1728); Peripheral Vascular Disease (2002)
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Event Date 05/20/2014 |
Event Type
Injury
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Event Description
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The angiosculpt device was unable to cross the sfa lesion.In attempting to retrieve the device, it appeared to be caught on the wire.The physician removed the wire from the balloon and attempted to re-wire with a new 0.014" wire but would not pass through the hub.The physician then severed the hub from the shaft with a scalpel.Once this was accomplished, the physician was able to re-wire the device and retrieve the balloon safely.Additional information received on (b)(6) 2014: the physician met with resistance as he was pushing a 5.0x200mm angiosculpt device to the distal sfa.He continued to push the catheter and felt it "telescope" in on itself.When he tried to withdraw the catheter, the device seemed stuck, perhaps on a spicule of calcium.The physician pulled quite hard to try and withdraw.
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Manufacturer Narrative
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Additional intervention was performed to remove the angiosculpt device.The physician then rewired the lesion to complete the procedure, thus resulting in prolongation of the case.The angiosculpt device was returned in two pieces.Visual examination confirmed the luer was cut from the shaft approximately 10 mm from the strain relief.The inner lumen inside the luer is accordion and the transition tubing is damaged.The shaft and inner member both appeared kinked.During functional testing, a 0.014" guide wire was inserted through the distal and proximal end of the separated distal section, but was unable to pass possibly due to an occluded lumen.The guide wire was also inserted through the proximal separated section of the device, but was unable to pass at the luer due to the accordion inner lumen.The information provided on the complain form and the evidence observed during lab analysis suggests the device experienced exertion of force applied by the user.
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