BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7213 |
Device Problems
Difficult to Remove (1528); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2022 |
Event Type
malfunction
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Event Description
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Reportable based on device analysis completed on 26-may-2022.It was reported that removal difficulties into the guide catheter and device interaction encountered.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left main artery.After stent deployment, a 6.00mm x 15mm nc emerge balloon catheter was advanced for post dilation.After the balloon was inflated to 12 atmospheres, the device would not come back into the guide.After several attempts of pulling negative and trying to remove the balloon through the guide catheter, the physician pulled negative on the balloon and removed the 6fr guide catheter manually together with the balloon and the wire.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed balloon catheter froze on wire.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter with an unknown guidewire.The device was visually and microscopically examined.The guidewire returned with the device was froze on wire and not removable due to the shaft damage of the device.Removal of the wire would likely cause further damage.There was contrast in the inflation lumen and the balloon.The inflation lumen was stretched for a length of 26.6cm just distal to the midshaft bond.The shaft was stretched down just distal to the rapid port exchange for a length of 4mm.There was blood in the guidewire lumen.At 44mm from the tip of the device, for a length of 3mm, the guidewire lumen was buckled.The balloon was loosely folded, and the tip was damaged and prolapsed.The guidewire was returned within the balloon catheter.The exposed portion of the wire was measured with a laser micrometer to measure the outer diameter which was within compatible use according to the instruction for use (ifu).There was unreported shaft and tip damage to the device that would cause resistance during device advancement or removal.The buckling of the guidewire lumen is indicative to an interaction with the guidewire.
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