BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 86706 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to boston scientific for analysis.Visual inspection found the device has a kink on the shaft, also the tip is detached from the shaft with no adhesive residues observed.Functional test shows that the plunger functioned properly.No abnormal resistance was felt when actuating the steering mechanism.The test curve passes; the curve is less than the specification of 4.5cm.The curve also passes the out-of-plane test.The device passed the dimensional test.Microscope inspection found the tip is out of the shaft and no adhesive residues were observed.X-ray inspection showed tip detachment confirmed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
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Event Description
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Reportable based on device analysis completed on 21oct2021.It was reported that before a procedure to treat atrial fibrillation a dynamic xt catheter was selected for use.The shaft was bent while removing the packaging, the package was in good conditions.The issue was solved by exchanging the catheter and the procedure was successfully completed with no patient complications.However, device analysis revealed the tip was detached from the shaft.
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