Model Number BNI35BDH |
Device Problems
High Readings (2459); Patient Device Interaction Problem (4001)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 11/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).Manufacturer's ref.# (b)(4).
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Event Description
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It was reported that a patient underwent a ventricular ablation procedure with right ventricle outflow (rvot) origin with a thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, the impedance rose over 400 ohms when the catheter was moved to the pulmonary artery.After performed 3 ablations, a decrease in the patient¿s blood pressure was noticed.Cardiac tamponade was confirmed by echocardiography, and pericardiocentesis was performed to drain venous blood from the pericardial space.Noradrenaline was administered and the patient had no serious symptoms.Blood pressure was restored.Physician believes the perforation might have occurred during catheter manipulation in the ventricle, physician stated he felt resistance while advancing the catheter; however, did not attribute the causality of the event to a bwi product malfunction.Patient had recovered from the issue.There¿s no indication that prolonged hospitalization was required.The reported issue of high impedance is not considered to be mdr reportable since there is no indication that the user-defined cut-off was exceeded the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available, it will be reviewed and processed accordingly.
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Manufacturer Narrative
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On 12/29/2020, biosense webster inc.Received additional event information.It was reported that the patient was a 58-yer-old female.Patient had fully recovered from the issue.Transseptal puncture was not done.There was no evidence of steam pop during the ablation.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number 30366626l identified no internal actions related to the reported complaint condition.Still no device has been received for analysis, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Search Alerts/Recalls
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