BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number H74939135402010 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that shaft break occurred.Vascular access was obtained bidirectionally with anterograde approach.The 99% stenosed, 17cm long target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).After a guidewire crossed the lesion, a 4x20 sterling balloon catheter was advanced for pre-dilatation.A 4mmx20mmx144cm coyote¿ es balloon catheter was advanced for post dilation.However, during procedure, the shaft broke and remained on the guide wire.The balloon was withdrawn together with the guidewire with no remnant found inside the patient and the procedure was completed.No patient complications were reported and the patient's status was good.
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Manufacturer Narrative
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Device evaluated by mfr.: returned device consisted of a coyote es balloon catheter with blood in the balloon and lumen.The balloon was loosely folded.There was damage (twisted) to the port/exit notch.Microscopic and tactile inspection revealed numerous kinks in the hypotube.The outer shaft was separated 35cm from the tip of the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Event Description
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It was reported that shaft break occurred.Vascular access was obtained bidirectionally with anterograde approach.The 99% stenosed, 17cm long target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).After a guidewire crossed the lesion, a 4x20 sterling balloon catheter was advanced for pre-dilatation.A 4mmx20mmx144cm coyote es balloon catheter was advanced for post dilation.However, during procedure, the shaft broke and remained on the guide wire.The balloon was withdrawn together with the guidewire with no remnant found inside the patient and the procedure was completed.No patient complications were reported and the patient's status was good.
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