Model Number H749RB4350100 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/29/2016 |
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 saline leak occurred.The target lesion was located in the coronary artery.A 10/3.50 mm flextome¿ cutting balloon¿ was selected for use.During the procedure, after passing the device though the lesion, the balloon failed to inflate when viewed under fluoroscopy.Upon removal from the patient's body, the device was inflated and contrast media and saline were noted to be leaking from the balloon.The procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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Device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear starting at the proximal markerband and extending 10mm to the distal markerband was identified.A visual and microscopic examination observed no damage to the tip, blades, or markerbands.All blades were present and fully bonded to the balloon surface.The hypotube was kinked at several locations along its length.This type of damage is consistent with excessive force being applied to the delivery system.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 a saline leak occurred.The target lesion was located in the coronary artery.A 10/3.50mm flextome¿ cutting balloon¿ was selected for use.During the procedure, after passing the device though the lesion, the balloon failed to inflate when viewed under fluoroscopy.Upon removal from the patient's body, the device was inflated and contrast media and saline were noted to be leaking from the balloon.The procedure was completed with another of the same device.No patient complications were reported.
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Search Alerts/Recalls
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