BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number M001BP50620B0 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/18/2018 |
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 the blade was found to be partially detached upon removal from the patient.A 6mm x 2cm x 50cm peripheral cutting balloon¿ was selected for use for a shunt percutaneous transluminal angioplasty procedure.After deflation of the balloon, slight resistance was encountered upon removal of the device from the body.Once the device was removed from the non-bsc sheath, outside of the patient's body, it was noted that the blade of the device was partially detached.Then when the physician touched the blade, it fully detached.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 evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that a section of one of the blades, approximately 10mm in length had completely detached from the proximal end of the balloon material.This detached section of blade was also returned for analysis.The next section of blade measuring approximately 1mm in length was noted to have lifted from the balloon material.The entire pad underneath the damaged blade was intact and fully bonded to the balloon material.The remaining section of blade measuring 9mm in length was undamaged and fully bonded to the balloon material.The entire 2cm of blade was accounted for.The damage identified can potentially be a result of the resistance encountered during the advancement or withdrawal of the device.All other blades were intact and fully bonded to the balloon material.No issues were noted with the blades or pads that could have contributed to the complaint incident.A visual examination of the balloon noted that the balloon was unfolded which indicates it had been subjected to positive pressure.A microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination identified no damage or any issues along the length of the device.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Event Description
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It was reported that the blade was found to be partially detached upon removal from the patient.A 6mm x 2cm x 50cm peripheral cutting balloon¿ was selected for use for a shunt percutaneous transluminal angioplasty procedure.After deflation of the balloon, slight resistance was encountered upon removal of the device from the body.Once the device was removed from the non-bsc sheath, outside of the patient's body, it was noted that the blade of the device was partially detached.Then when the physician touched the blade, it fully detached.The procedure was completed with another of the same device.No patient complications were reported.
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