BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE¿ AND WIRECLIP¿ TORQUER; CATHETER, CORONARY, ATHERECTOMY
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Model Number H802232390012 |
Device Problem
Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the rotawire was able to be removed with no issues from the rotablator rotalink plus device.The device body was kinked, the distal tip was stretched and the solder weld was missing.The overall length and outer diameter (od) of the middle and proximal sections of the device were within specification.Dimensional inspection of the od of the distal tip could not be performed due to the device condition.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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Reportable based on device analysis completed on 12-oct-2017.It was reported that a rotawire kink occurred.A rotawire¿ was selected for use.During the procedure, it was noted that the rotawire became kinked.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that the solder weld was missing.
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Search Alerts/Recalls
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