BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139505 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 11/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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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.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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Event Description
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It was reported a patient underwent a cardiac ablation procedure and patient experienced cardiac tamponade treated with a surgical intervention and extended hospitalization.Transseptal puncture occurred with abbott brk needle extra sharp and ablation was performed.During the procedure, a pericardial effusion was discovered when scanning the area with an ice (intracardiac echocardiography) soundstar catheter.A pericardiocentesis was performed and 150 ccs of fluid was removed from the patient.This stabilized the patient moderately, however, they continued to lose blood.The patient was then sent to open heart surgery.Last known information on outcome is patient was stabilized.The physician stated that they believe the effusion may have been caused by ablation or could have been caused when the vizigo and q-dot catheter were "flung back into the left atrium".No evidence of steam pop and settings were regular default qmode settings.No error messages were noted on the equipment.The cardiac ablation catheter is the most suspected device as it is the ablation catheter that delivered rf (radiofrequency) energy directly to cardiac tissue.No tissue injuries by the other devices were reported.
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Manufacturer Narrative
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On 3-jan-2024, the bwi product analysis lab received the device for evaluation.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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On (b)(6) 2024, the product investigation was completed.It was reported a patient underwent a cardiac ablation procedure and patient experienced cardiac tamponade treated with a surgical intervention and extended hospitalization.Transseptal puncture occurred with abbott brk needle extra sharp and ablation was performed.During the procedure, a pericardial effusion was discovered when scanning the area with an ice (intracardiac echocardiography) soundstar catheter.A pericardiocentesis was performed and 150 ccs of fluid was removed from the patient.This stabilized the patient moderately, however, they continued to lose blood.The patient was then sent to open heart surgery.Last known information on outcome is patient was stabilized.Device evaluation details: the device 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 force features were tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The other device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device 31177531l number, and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis, other issues or circumstances may have occurred during the usage of the device that compromised its performance.The root cause of the adverse event remains unknown.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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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Manufacturer Narrative
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Udi related data quality updates only.Correction to the initial and follow up 1 mdrs, incomplete udi was provided.Section d4.Primary udi number has been updated with full udi (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
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Search Alerts/Recalls
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