BIOSENSE WEBSTER, INC. (JUAREZ) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
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Model Number D-1282-08-S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
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Event Date 11/09/2016 |
Event Type
Injury
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Manufacturer Narrative
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No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record was reviewed.The dhr review verifies that the devices were manufactured in accordance with documented specification and procedures.Concomitant products: distributed - sterilmed reprocessed soundstar eco catheter; model #: m-5723-16.Lot#: 1957394.(b)(4).Event description continuation: the transseptal puncture was performed with a st.Jude medical brk xs.Sheath was a st.Jude medical sl1 8.5 french.Generator parameters were not reported, as no ablation was performed.There is no information regarding irrigated catheter flow.Patient received anticoagulation during the procedure with activated clotting time at 315 seconds.There were no errors reported on any bwi equipment during the procedure.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.Although the physician indicated that the injury possibly occurred as a result of cannulation of the coronary sinus, biosense webster, inc.Will conservatively report the pentaray navigational eco catheter, as it was also being used at the time that the tamponade was identified.
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Event Description
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It was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a c3 coronary sinus refstar - deflectable catheter and a pentaray navigational eco catheter and suffered a cardiac tamponade requiring surgical intervention.During the mapping phase, while positioning the c3 coronary sinus refstar - deflectable catheter, the physician attempted placement twice.Upon the third attempt, the c3 coronary sinus refstar - deflectable catheter, was placed further into the coronary sinus and appeared to be more stable.The transseptal puncture was performed and a st.Jude medical sl1 sheath was advanced into the left atrium.A pentaray navigational eco catheter was inserted into the sheath and the fast anatomical map (fam) construction began.Approximately 2 minutes into the fam, the patient became hypotensive.A sterilmed reprocessed soundstar catheter was advanced into the ventricle and confirmed a large effusion/tamponade.Protamine was administered, pericardiocentesis was performed, and blood was auto-transfused.The physician indicated that the coronary sinus may have been dissected during cannulation.A cardiovascular surgeon was consulted and agreed that the coronary sinus was the likely area of injury.The patient was transferred to the operating room for open heart surgery in stable condition.The patient required extended hospitalization as a result of this adverse event.There were no factors cited that may have contributed to the adverse event.The physician¿s opinion regarding the cause of the adverse event is that it was related to the c3 coronary sinus refstar - deflectable catheter, cannulation of the coronary sinus.
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Manufacturer Narrative
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The bwi failure analysis lab received the device for evaluation on 1/9/17.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.(b)(4).
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Manufacturer Narrative
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Manufacturer's ref.No: (b)(4).It was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a c3 coronary sinus refstar - deflectable catheter and a pentaray navigational eco catheter.During the mapping phase, while positioning the c3 coronary sinus refstar - deflectable catheter, the physician attempted placement twice.Upon the third attempt, the c3 coronary sinus refstar - deflectable catheter, was placed further into the coronary sinus and appeared to be more stable.The transseptal puncture was performed and a st.Jude medical sl1 sheath was advanced into the left atrium.A pentaray navigational eco catheter was inserted into the sheath and the fast anatomical map (fam) construction began.Approximately 2 minutes into the fam, the patient became hypotensive.A sterilmed reprocessed soundstar catheter was advanced into the ventricle and confirmed a large effusion/tamponade.Protamine was administered, pericardiocentesis was performed, and blood was auto-transfused.The physician indicated that the coronary sinus may have been dissected during cannulation.A cardiovascular surgeon was consulted and agreed that the coronary sinus was the likely area of injury.The patient was transferred to the operating room for open heart surgery in stable condition.The patient required extended hospitalization as a result of this adverse event.The returned device was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for electrical performance and it was found within specifications.After that, deflection test was performed and the catheter passed.The catheter was evaluated for eeprom, and the functionality of the sensor of the catheter was tested on carto3 system.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.Finally, an irrigation test was performed and the catheter failed; occlusion was observed.Further examination showed that the irrigation tubing had no damage; however crystallized white material was observed inside the tubing.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Catheter failed during irrigation test; however this condition is not related to the tamponade reported.The root cause of the tamponade remains unknown.Based on the available analysis finding results, the failure mode does not appear to be caused by any internal biosense webster, inc.Processes.
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Manufacturer Narrative
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Additional information was received on february 3, 2017.The sterilmed reprocessed soundstar catheter was only in the right atrium.The only catheter advanced into the coronary sinus was the c3 coronary sinus refstar - deflectable catheter.Surgery revealed that the site of injury was the right atrial appendage.Physician¿s opinion regarding the cause of the adverse event is that he may have perforated the right atrial appendage with the transseptal sheath.(b)(4).
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