BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number 24628 |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter facility name: (b)(6).
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Event Description
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It was reported that the blade detached and about half of one blade remained inside patient.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified brachial vein.A 5.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During the procedure, the lesion was dilated with this device and was attempted to be removed as usual, however, resistance was felt when retracting it into the sheath.At that time, removing the entire sheath was considered, however, only the balloon was removed.When it was checked after removal, it was found that one of the four blades was damaged.A closer inspection revealed that half of the damaged blade was missing and was thought to be still inside the body.Subsequently, echo confirmed that there was an object near the tip part of the sheath that was probably a blade.Since it was in close contact with the vessel wall and considered unlikely to flow, it was then decided to observe the patient.Per physician's opinion, it was unknown if the event could have been avoided if he had removed the sheath when he removed the device.The calcification was not severe, and the device was not used more aggressively than usual.No further complications were reported and the patient was in good condition post procedure.
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Event Description
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It was reported that the blade detached and about half of one blade remained inside patient.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified brachial vein.A 5.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During the procedure, the lesion was dilated with this device and was attempted to be removed as usual, however, resistance was felt when retracting it into the sheath.At that time, removing the entire sheath was considered, however, only the balloon was removed.When it was checked after removal, it was found that one of the four blades was damaged.A closer inspection revealed that half of the damaged blade was missing and was thought to be still inside the body.Subsequently, echo confirmed that there was an object near the tip part of the sheath that was probably a blade.Since it was in close contact with the vessel wall and considered unlikely to flow, it was then decided to observe the patient.Per physician's opinion, it was unknown if the event could have been avoided if he had removed the sheath when he removed the device.The calcification was not severe, and the device was not used more aggressively than usual.No further complications were reported and the patient was in good condition post procedure.
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Manufacturer Narrative
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E1.Initial reporter facility name: (b)(6) hospital.Device evaluated by manufacturer: the device was returned for analysis.The recommended sheath size for this device as per specification is a minimum 6fr.The sheath used by the customer was not returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that approximately 4mm of the proximal end of one of the blades was lifted distally from the balloon material.The remaining 16mm of the blade and entire blade pad remained bonded to the balloon material.The entire blade was present and accounted for.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.No issues were identified with the balloon material which could potentially have contributed to this complaint.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 found the shaft of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.
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