Model Number M001BPM3515140F0 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Event Description
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It was reported that a shaft detachment occurred.The 90% stenosed target lesion was locate in the mildly tortuous and mildly calcified left femoral artery.A 3.50 mm/4.5 cm/140 cm small peripheral cutting balloon was selected for use.During preparation, it was noted that the balloon protector was difficult to remove from the balloon.Subsequently, the shaft part became detached.The procedure was completed with another of the device.No patient complications were reported and the patient's condition was good.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.A visual examination of the balloon, blades, tip was performed and revealed no damage.The balloon protector was still attached to the balloon.Internal dimension of the balloon protector was taken and met specified range.A visual and tactile examination of the hypotube shaft was taken and revealed that no kinks were found along the shaft.Also, a visual and tactile examination of the polymer shaft extrusion found that the mid-shaft showed signs of stretching and had detached 4mm proximal from extruded polymer shaft.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 considered handling damage as the event occurred without direct patient contact.(b)(4).
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Event Description
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It was reported that a shaft detachment occurred.The 90% stenosed target lesion was locate in the mildly tortuous and mildly calcified left femoral artery.A 3.50mm/ 4.5cm/140cm small peripheral cutting balloon¿ was selected for use.During preparation, it was noted that the balloon protector was difficult to remove from the balloon.Subsequently, the shaft part became detached.The procedure was completed with another of the device.No patient complications were reported and the patient's condition was good.
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Search Alerts/Recalls
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