ST. JUDE MEDICAL, INC. INQUIRY STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number IBI-81104 |
Device Problem
Component Misassembled (4004)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2020 |
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 the final report.
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Event Description
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During a procedure, after the catheter was inserted into the patient it was noted that there were more than the expected 10 electrodes on the fluoroscopy image.The catheter was replaced with another catheter and the procedure was completed with no adverse consequences to the patient.
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Manufacturer Narrative
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Corrected information: d4, h4.Additional information: g4, g7, h2.
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Manufacturer Narrative
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The device was not returned for analysis; however, it was confirmed that the package was labeled with the incorrect information.From previous investigation it was confirmed that the catheter from the batch number 7397352 were with 10 electrodes, was packaged with the label of the catheter from the batch number 7397307 were with 14 electrodes and vice versa.
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Search Alerts/Recalls
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