Model Number 3851 |
Device Problems
Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/15/2023 |
Event Type
Injury
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Event Description
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It was reported that the balloon ruptured, a blade detached and additional intervention was necessary for removal.The target lesion was located in the highly calcified and diffusely lesioned first diagonal branch segment.The target lesion was predilated using 1.50 mm and 2.00 mm balloons before a 10 mm x 2.00 mm wolverine coronary cutting balloon was introduced for treatment.Difficulty was encountered during insertion of the device and the surgeon believed the device may have been caught in severe calcification.A non-boston scientific guide extension catheter was used to successfully store and remove the device, although difficulty was experienced.Upon inspection of the wolverine after removal, the shape of the balloon had collapsed considerably and a rupture was noted.Only two of three blades were visualized.Intravascular ultrasound could not be completed due to the condition of the vessels and the location of the detached blade could not be confirmed.The procedure was completed.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.Visual and tactile inspection was performed.The balloon was returned with a v shaped tear measuring approximately 5mm in length.Multiple kinks were noted along the hypotube shaft.The polymer extrusion was stretched just proximal of the port exchange and a kink was noted in the distal extrusion at the guidewire exit port.A detailed microscopic examination of the balloon material identified v shaped tear measuring approximately 5mm in length.One set of the blades were detached, 8.5mm of the blades was not attached to the balloon and the remaining 1.5mm of the blade was attached to the castpad.A detailed microscopic examination confirmed that the blade castpad was fully intact.The other two sets of blades were fully bonded on the balloon and did not exhibit any signs of damage.Tip showed no signs of tip damage.Multiple kinks were noted along the hypotube shaft.A microscopic examination of the proximal and distal markerbands identified no damage.
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Event Description
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It was reported that the balloon ruptured, a blade detached and additional intervention was necessary for removal.The target lesion was located in the highly calcified and diffusely lesioned first diagonal branch segment.The target lesion was predilated using 1.50 mm and 2.00 mm balloons before a 10 mm x 2.00 mm wolverine coronary cutting balloon was introduced for treatment.Difficulty was encountered during insertion of the device and the surgeon believed the device may have been caught in severe calcification.A non-boston scientific guide extension catheter was used to successfully store and remove the device, although difficulty was experienced.Upon inspection of the wolverine after removal, the shape of the balloon had collapsed considerably and a rupture was noted.Only two of three blades were visualized.Intravascular ultrasound could not be completed due to the condition of the vessels and the location of the detached blade could not be confirmed.The procedure was completed.
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Search Alerts/Recalls
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