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E1.Initial reporter phone: (b)(6).The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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.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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It was reported that a patient underwent a premature ventricular contraction cardiac ablation, which included the use of a decanav electrophysiology catheter, and the patient experienced cardiac tamponade.It was also reported that one of the electrodes came off which appeared stuck inside the sheath and another electrode was torn.While right ventricular (rv) mapping was done with the first decanav catheter, fast-anatomical mapping (fam) for right ventricular outflow tract (rvot) could not be obtained.Therefore, the decanav catheter was replaced with the second decanav catheter (lot# 31198319m).After the completion of mapping for rv and aorta (ao) with the use of the second decanav catheter, the procedure went back to rv once again.While mapping, fluoroscopy revealed an unknown object in the agilis sheath.Therefore, the catheter and the sheath were removed from the patient¿s body and were flushed to check the inside.However, there was nothing found.When the decanav catheter was inserted in the patient¿s body for mapping again, noise occurred on the electrodes 3 and 4 of the decanav.When the catheter was removed outside of the patient¿s body, and was checked, the 3rd electrode was torn, and the 4th electrode had been lost completely from the catheter.Though the inside of the sheath was checked, and a check was done by fluoroscopy, the 4th electrode could not originally be found in the sheath, in the cardiac cavity or anywhere else.There was no significant discomfort during the catheter operation or when the catheter was inserted into the sheath.Additional information was received indicates that the 4th electrode, which was initially reported as missing, was found stuck inside the abbott agilis sheath.While mapping, fluoroscopy revealed an unknown object in the agilis sheath.When checking for the electrode under fluoroscopy, part of the electrode appeared to be stuck inside the sheath.The sheath and the catheter were replaced, and the procedure was completed.There was no issue during insertion or removal of the catheter.After the procedure, a nurse found that patient was pale.Then, an examination revealed a cardiac tamponade.Pericardiocentesis was performed and the patient recovered and was discharged from the hospital.Ablation was performed before pericardial effusion or tamponade was confirmed.Steam pop was not confirmed.Atrial septal puncture was not performed.Sheath used was agilis and sl0, both french sizes were 8.5fr.The mapping and noise issues were assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The cardiac tamponade is conservatively being reported under the mapping catheter (decanav).Follow up is being conducted on what ablation catheter was used in the procedure.
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