BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number UNK_QDOT MICRO |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Paralysis (1997)
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Event Date 02/20/2024 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure which included a qdot micro¿ catheter and the patient experienced phrenic nerve injury.The procedure may have been about two weeks ago, and the physician did not share information on what symptoms the patient was experiencing.Ablating by the right veins in the left atrium (la) and did not pace beforehand to confirm where the phrenic nerve was.The physician did not share any further details.There was no indication or anything that they saw that would signify that a phrenic injury occurred.It was during a patient follow-up when they learned that there was some phrenic injury.The physician reported that he does not believe it was a malfunction of the catheter but more that it was based on patient anatomy.The physician attributed the adverse event to the procedure and that these things happen periodically.
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Manufacturer Narrative
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Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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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