Catalog Number D133604IL |
Device Problems
Signal Artifact/Noise (1036); Break (1069); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter and a wires exposed issue occurred.Initially an ecg signal interference and deflection issues were reported.During the procedure, the signal interference (noise) was observed on intracardiac (ic), body surface (bs), or all ecg (bs + ic) channels, and catheter was unable to deflect or relax completely.A second device was used to complete the procedure.There was no adverse event reported on the patient.Pictures and video provided.Additional information was received on 26-mar-2024.Clarification response stated that the wire reflecting in the picture provided was related to wires exposed or physical damage to the catheter.The polyurethane coating that wrapped the catheter was broken.There was difficulty reversing the catheter during the procedure.The synaptic medical,s085332l0,l0 long sheath was used.
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Manufacturer Narrative
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The pictures and video were reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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The bwi product analysis lab received the device for evaluation on 22-apr-2024.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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