Model Number H749CBM3400150 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/05/2018 |
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 balloon detachment occurred.A 4.0 x 15 flextome cutting balloon was selected for use.During preparation, outside patient's body, the balloon came off with blue sheath covering the balloon.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.The balloon material was noted to have completed detached from the shaft of the device and was returned still within the blue balloon protective sheath.Multiple kinks were also noted along the length of the hypotube.Balloon material was noted to have completely detached from the shaft of the device and was returned still held within the blue balloon protective sheath.A visual and microscopic examination identified that the balloon material had completely detached from the shaft of the device.It detached from the device approximately 8mm proximal to the proximal edge of the proximal markerband.The balloon material was returned within the blue balloon protective sheath.The investigator removed the balloon material from the sheath.No issues were noted with the balloon material that could have contributed to the complaint incident.Visual and microscopic investigation identified no damage or any issues with the blades, tip or markerbands of the device that could have contributed to the complaint incident.All blades were present and fully bonded to the balloon material.Visual and tactile examination of the hypotube noted multiple kinks along its length.This type of damage is consistent with excessive force being applied to the delivery system.The balloon protector was received in position over the balloon.Due to the condition of the returned device it was not possible to apply a vacuum; however, the investigator removed the balloon protector sheath and slight resistance was encountered.The lack of vacuum may have resulted in the encountered resistance.The returned balloon protector inner dimension was verified at 0.0425 inch using a pin gauge and was within the specified range.No issues were identified that could have contributed to the complaint incident.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
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Event Description
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It was reported that balloon detachment occurred.A 4.0 x 15 flextome cutting balloon was selected for use.During preparation, outside patient's body, the balloon came off with blue sheath covering the balloon.There were no patient complications reported.
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Search Alerts/Recalls
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