BOSTON SCIENTIFIC - MAPLE GROVE APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number H7493895912200 |
Device Problems
Detachment Of Device Component (1104); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that catheter removal difficulties were encountered and balloon detachment occurred.The target lesion was located in the heavily calcified carotid artery.After a non-bsc filter wire was unable to cross the lesion, a 2.00 mm x 12 mm apex¿ balloon catheter was advanced for dilation.However, after dilation was performed, when the physician went to pull the balloon out of the body, he was not able to retract it.Eventually, he was able to get the balloon shaft back.When fluoroscopy was performed, it was noted that the balloon marker was still in the carotid artery.The detached balloon was retrieved with a 10 mm snare.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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device evaluated by mfr: returned product consisted of an apex inner shaft that was stuck on an unidentified 0.14" guidewire.The shaft was microscopically examined.The inner shaft was buckled and stretched on the guidewire.A measurement could not be taken due to the condition of the device.The separated ends of the inner shaft are consistent with tensile overload.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Event Description
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It was reported that catheter removal difficulties were encountered and balloon detachment occurred.The target lesion was located in the heavily calcified carotid artery.After a non-bsc filter wire was unable to cross the lesion, a 2.00mm x 12mm apex balloon catheter was advanced for dilation.However, after dilation was performed, when the physician went to pull the balloon out of the body, he was not able to retract it.Eventually, he was able to get the balloon shaft back.When fluoroscopy was performed, it was noted that the balloon marker was still in the carotid artery.The detached balloon was retrieved with a 10mm snare.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
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