BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7163 |
Device Problem
Deflation Problem (1149)
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Patient Problems
Arrhythmia (1721); Myocardial Infarction (1969); Vascular Dissection (3160)
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Event Date 07/31/2021 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event: 18 years or older.
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Event Description
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It was reported that balloon deflation failure and subsequent patient complications occurred.Vascular access was obtained via the radial artery.The 90% tightly stenosed, 3x30mm, concentric, de novo target lesion was located in the mildly tortuous and non-calcified left anterior descending (lad) artery.A 2.50mm x 15mm emerge balloon catheter was advanced for pre-dilation.On the first inflation, the balloon was slowly inflating up to 12 atmospheres.However, after the second inflation, the balloon was not able to deflate even after using a different inflation/deflation device.The patient went into ventricular tachycardia and was in a critical situation.The patient also experienced st elevation myocardial infarction.A deep intubation of the catheter was performed and the device was removed together with the guide catheter and the wire.The angiography showed a dissection of the medium lad.When the procedure was completed, there were two stents implanted in the lad.No further patient complications were reported.
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Event Description
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It was reported that balloon deflation failure and subsequent patient complications occurred.Vascular access was obtained via the radial artery.The 90% tightly stenosed, 3x30mm, concentric, de novo target lesion was located in the mildly tortuous and non-calcified left anterior descending (lad) artery.A 2.50mm x 15mm emerge balloon catheter was advanced for pre-dilation.On the first inflation, the balloon was slowly inflating up to 12 atmospheres.However, after the second inflation, the balloon was not able to deflate even after using a different inflation/deflation device.The patient went into ventricular tachycardia and was in a critical situation.The patient also experienced st elevation myocardial infarction.A deep intubation of the catheter was performed and the device was removed together with the guide catheter and the wire.The angiography showed a dissection of the medium lad.When the procedure was completed, there were two stents implanted in the lad.No further patient complications were reported.It was further reported that the physician considered the balloon extraction contributed to the dissection.
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Manufacturer Narrative
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A2: age at time of event - 18 years or older.
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Manufacturer Narrative
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A2: age at time of event - 18 years or older.Returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There were numerous significant bends to the hypotube of the device.There was contrast in the inflation lumen and the balloon.There was blood in the guidewire lumen, and the balloon was loosely folded.At 45mm from the tip of the device, the guidewire lumen was stretched down for a length of 5mm.At 40mm from the tip, the guidewire lumen was kinked.The distal portion of the balloon was prolapsed.The tip of the device was prolapsed and damaged.The device was soaked for a period of time to break up the contrast, it was then prepped with an inflation device filled with water to inflate the device to the rated burst pressure.The balloon was able to be inflated, maintained pressure , and deflated with no issue or irregularity.
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Event Description
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It was reported that balloon deflation failure and subsequent patient complications occurred.Vascular access was obtained via the radial artery.The 90% tightly stenosed, 3x30mm, concentric, de novo target lesion was located in the mildly tortuous and non-calcified left anterior descending (lad) artery.A 2.50mm x 15mm emerge balloon catheter was advanced for pre-dilation.On the first inflation, the balloon was slowly inflating up to 12 atmospheres.However, after the second inflation, the balloon was not able to deflate even after using a different inflation/deflation device.The patient went into ventricular tachycardia and was in a critical situation.The patient also experienced st elevation myocardial infarction.A deep intubation of the catheter was performed and the device was removed together with the guide catheter and the wire.The angiography showed a dissection of the medium lad.When the procedure was completed, there were two stents implanted in the lad.No further patient complications were reported.It was further reported that the physician considered the balloon extraction contributed to the dissection.
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