BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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Model Number 24634 |
Device Problems
Difficult to Remove (1528); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2021 |
Event Type
malfunction
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Event Description
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It was reported that the device was difficult to remove.Vascular access was obtained via contralateral approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified common femoral artery.After advancing a 6 french non-boston scientific sheath, a 6.00mm / 2.0cm / 135cm peripheral cutting balloon was selected for use.Due to lesion severity, it could not be dilated completely.Five inflations were performed at 10 atmospheres.When removing the device, the blade caught on the tip of the sheath, and it was difficult to remove.To avoid shaft separation, the balloon and sheath were successfully removed together as a system.The blade did not dislodge, but it was suspected that blade deformation resulted in the removal difficulty.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for evaluation.A visual and microscopic examination was performed on the returned device.It was noted that one of the blades was kinked/damaged at a location approximately 15mm of the proximal of the distal tip.All the blades and blade pads remained fully bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered treating a challenging lesion.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A microscopic examination of the balloon material identified no issues 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 and stretched/damaged beginning approximately 770mm distal of the strain relief and extending approximately 22mm distally.This type of damage is consistent with excessive tensile force being applied to the device.No other issues were identified during the product analysis.
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Event Description
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It was reported that the device was difficult to remove.Vascular access was obtained via contralateral approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified common femoral artery.After advancing a 6 french non-boston scientific sheath, a 6.00mm / 2.0cm / 135cm peripheral cutting balloon was selected for use.Due to lesion severity, it could not be dilated completely.Five inflations were performed at 10 atmospheres.When removing the device, the blade caught on the tip of the sheath, and it was difficult to remove.To avoid shaft separation, the balloon and sheath were successfully removed together as a system.The blade did not dislodge, but it was suspected that blade deformation resulted in the removal difficulty.The procedure was completed with a different device.No patient complications were reported.
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Search Alerts/Recalls
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