BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7313 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 56.7cm distal of the strain relief.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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Reportable based on device analysis completed on 16dec2019.It was reported that shaft kink occurred.A 2.25mm x 15mm nc emerge balloon catheter was selected for use.However, the device could not be loaded over the guide wire due to kink in the shaft.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed shaft detachment.
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