Catalog Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 08/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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E1.Initial reporter phone: (b)(6).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 with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac perforation requiring a pericardiocentesis.After sound merge, the ablation was started from left pulmonary vein (lpv).When about 80% of the ablation was completed, the blood pressure decreased.The pericardial effusion was confirmed by transthoracic echocardiography and cardiac tamponade was diagnosed.So pericardiocentesis was performed.Blood pressure was restored by drainage.Subsequent ablation procedures were discontinued and the patient was discharged to intensive care unit (icu).Timing was during lpv ablation.The drainage was conducted by the pericardiocentesis.Atrial septal puncture was performed by rf needle.The ablation was performed before pericardial effusion or tamponade was detected.Steam pop was not confirmed.Irrigation catheter flow rate setting was pre 1 sec, post 1 sec.Description of health hazard was a cardiac tamponade.Method of cf monitoring was dashboard; vector; visitag.Causal relationship with the product was unknown.Physician's opinion on the relationship between the event and the product was that the product could be used as usual.The physician did not know at what timing the perforation occurred.There was no abnormality before using the product.There was no abnormality while using the product.The medical history/treatment history/other diseases currently being treated was sick sinus syndrome and 1st degree atrioventricular block.
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Manufacturer Narrative
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Additional information was received on 15-sep-2023.The adverse event was discovered during use of biosense webster products.Patient improved.Also, the patient¿s age, gender and weight were provided.Therefore, updated the a.Patient information section.Additional information was received on 11-oct-2023.The patient did not require extended hospitalization because of the adverse event.Also, the physician¿s name and the generator information were provided.Therefore, updated the e.Initial reporter and d 10.Concomitant medical products and therapy dates sections.The bwi product analysis lab received the device for evaluation on 28-sep-2023.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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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac perforation requiring a pericardiocentesis.The device evaluation was completed on 13-oct-2023.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.Physician's opinion on the relationship between the event and the product was that the product could be used as usual.He/she did not know at what timing the perforation occurred.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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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