ST. JUDE MEDICAL, INC INQUIRY ELECTROPHYSIOLOGY CATHETER, INQUIRY AFOCUS II EB CATHETER, 110 CM LEN; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number D087023 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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During an atrial fibrillation procedure, the tip electrode detached from the catheter.The catheter was difficult to insert and became lodged within the introducer.Upon removal of the catheter from the introducer, the electrode was noted to be detached.The catheter and introducer were exchanged and the procedure completed with no adverse consequences to the patient.
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Manufacturer Narrative
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Additional information: d10, g4, h2, h3, h6.One decapolar, spiral loop, inquiry afocusii diagnostic catheter was received for evaluation.One image was also submitted for evaluation.The photograph appeared to show a detached distal tip electrode.Visual inspection of the returned catheter confirmed that the catheter tip was separated from the catheter blue shaft tip.Microscopic investigation revealed the catheter blue shaft tip was damaged and torn.The loop forming nitinol wire loop was detached and missing.The assembled conductor wire at the blue shaft tip was not visible, it was also separated with the tip electrode.The microscopic view of the blue shaft revealed the tip was stretched.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detached tip electrode is consistent with damage during use.
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