BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number H7493912408300 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr: returned product consisted of a nc quantum apex balloon catheter.The balloon was tightly folded.There was contrast in the inflation lumen.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 69 cm from the hub.The fracture faces were oval as if kinked prior to separation.There were numerous hypotube kinks.There was tip damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
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Event Description
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It was reported that shaft break occurred.The target lesion was located in the right coronary (rca) artery.After deploying a bsc stent, a 8 mm x 3.00 mm nc quantum apex balloon catheter was selected for post dilation.However, during preparation, the balloon shaft broke.The device was not inserted into the patient's body and the procedure was completed with another of the same device.No patient complications were reported.
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