BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7312 |
Device Problems
Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
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Patient Problems
Embolism (1829); Stenosis (2263); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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Event Date 04/24/2020 |
Event Type
Injury
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Event Description
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It was reported that a balloon rupture occurred resulting in removal difficulty, device fracture, no flow, and subsequent bypass surgery.The patient presented with chest pain.Vascular access was obtained via the radial artery.The non-totally occluded, concentric target lesion was located in a non-tortuous and severely calcified left anterior descending artery (lad).A 2.5 x 10mm wolverine cutting balloon was used for plaque modification before the 3.0 x 12mm nc emerge balloon catheter was advanced to treat the target lesion.On inflation up to 30 atmospheres, the balloon ruptured and when the physician tried to remove the device, significant resistance was encountered.After several removal attempts, only part of the balloon was removed and a dissection was noted where the balloon had been earlier.The physician attempted to rewire the vessel but was unable to do so due to the dissection.Angiogram revealed a balloon marker was lodged distally.As there was now no flow in the lad, a surgeon was called and the patient underwent coronary artery bypass graft (cabg).The patient was recovering well in stable condition.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 141.5cm distal of the strain relief.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.There was a circumferential tear 6mm from the proximal end of the balloon.The inner shaft was stretched down starting 19.5cm from the exit notch.The distal portion of the balloon and device was missing.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that a balloon rupture occurred resulting in removal difficulty, device fracture, no flow, and subsequent bypass surgery.The patient presented with chest pain.Vascular access was obtained via the radial artery.The non-totally occluded, concentric target lesion was located in a non-tortuous and severely calcified left anterior descending artery (lad).A 2.5 x 10mm wolverine cutting balloon was used for plaque modification before the 3.0 x 12mm nc emerge balloon catheter was advanced to treat the target lesion.On inflation up to 30 atmospheres, the balloon ruptured and when the physician tried to remove the device, significant resistance was encountered.After several removal attempts, only part of the balloon was removed and a dissection was noted where the balloon had been earlier.The physician attempted to rewire the vessel but was unable to do so due to the dissection.Angiogram revealed a balloon marker was lodged distally.As there was now no flow in the lad, a surgeon was called and the patient underwent coronary artery bypass graft (cabg).The patient was recovering well in stable condition.It was further reported that the device fragment was found to have lodged in a septal branch and surgeon decided not to remove it from the patient.
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