BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number H74939135254010 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/18/2017 |
Event Type
Injury
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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 balloon detachment occurred.The target lesion was located in the severely calcified vessel below the knee.A 2.5mm x 40mm x 146cm coyote¿ es balloon catheter was advanced to dilate the lesion.After several dilatations were performed, the device was attempted to be removed from the patient's body; however, the balloon got detached near the guidewire exit port.The detached balloon was then removed by snaring.The procedure was completed with a different device and vascular patency was observed.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of the coyote es balloon catheter in two pieces.The shafts and balloon were microscopically examined.There was blood in the inflation lumen and balloon.The balloon was loosely folded.There were numerous kinks proximal of the exit notch and throughout the distal shaft.There was a shaft separation 1mm distal of the exit notch.The inner shaft was buckled 3mm distal of the bi-component weld and in the balloon 4mm proximal of the distal markerband.The tip was damaged.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.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 balloon detachment occurred.The target lesion was located in the severely calcified vessel below the knee.A 2.5mm x 40mm x 146cm coyote¿ es balloon catheter was advanced to dilate the lesion.After several dilatations were performed, the device was attempted to be removed from the patient's body; however, the balloon got detached near the guidewire exit port.The detached balloon was then removed by snaring.The procedure was completed with a different device and vascular patency was observed.No patient complications were reported.
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