Model Number 24630 |
Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: date of event is approximated based on notification date.
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Event Description
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It was reported that a blade lifted from the cutting balloon.A 7.00mm / 2.0cm / 90cm peripheral cutting balloon was used in a procedure.Post procedure, when the physician was removing the balloon from the sheath, it was noted that the blade lifted from its position on the balloon.No portion of the device remained in the patients body.There were no patient complications and the patient was reported to be in good condition post procedure.
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Manufacturer Narrative
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B3: date of event: date of event is approximated based on notification date.Device analysis by mfr: a visual examination identified the returned balloon folds were relaxed.The device was attached to an encore inflation device and positive pressure was applied.A pinhole leak was identified 10mm proximal of the distal marker band.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.Visual and microscopic examination of the blades and pads found that 15mm of blade had lifted on one of the blades.The blade pad was fully intact.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device.All other blades were intact and fully bonded to the balloon material.No other damage or irregularities were found on the device.
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Event Description
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It was reported that a blade lifted from the cutting balloon.A 7.00mm / 2.0cm / 90cm peripheral cutting balloon was used in a procedure.Post procedure, when the physician was removing the balloon from the sheath, it was noted that the blade lifted from its position on the balloon.No portion of the device remained in the patients body.There were no patient complications and the patient was reported to be in good condition post procedure.
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Search Alerts/Recalls
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