BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
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Catalog Number D160901 |
Device Problems
Off-Label Use (1494); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 09/20/2023 |
Event Type
Injury
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Event Description
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It was reported a patient underwent an atrial fibrillation (afib) cardiac ablation procedure that included the use of an octaray mapping catheter and a piece of broken electrode was left inside the patient¿s body.During left atrial (la) anterior wall mapping, octaray b1-2 electrode was dislodged and entered into the left ventricle after being caught in a mechanical valve.The physician felt the octaray was slightly stuck, but felt resistance when the catheter was pulled, and when the catheter was removed from the patient's body, the electrode had been dislodged.Based on the results of the computed tomography (ct) after the procedure, it was highly likely that the 1-2 electrode remained in the posterior wall of the left ventricle.After assessing various risks, it was decided not to retrieve the electrode and the procedure was completed.The physician considered the possibility of retrieving the electrode by opening the chest, etc., but the risk of attempting to retrieve the electrode by opening the chest, etc., was judged to be higher than the risk of leaving the electrode in the patient's body, and the patient was followed up for observation.No abnormalities observed prior to or during use of the product.
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Manufacturer Narrative
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E 1.Initial reporter phone : (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31065223l number, and no internal action related to the complaint was found during the review.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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