MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 86706

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Ventricular Fibrillation (2130); Loss of consciousness (2418); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 07/25/2018

Event Type  Death  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.

Event Description

It was reported arrhythmia, cardiac arrest, loss of consciousness, hemodynamic instability, perforation, pericardial effusion, and patient death occurred.A dynamic xt diagnostic catheter, another manufacturer's diagnostic catheter, and another manufacturer's ablation catheter were selected for use during an accessory pathway ablation procedure.The catheters were advanced via femoral access sites; the dynamic xt was placed in the coronary sinus, while the other diagnostic catheter was used for his placement.Both catheters were placed at the beginning of the procedure and were not moved until the end of the procedure.The ablation catheter was used to search for the accessory pathway, and was therefore moved to locate the place where ablation would be delivered.Anticoagulation therapy was used intra-procedurally.Several rf deliveries were attempted, but none were successful; the arrhythmia the physician was attempting to ablate persisted.Average power during ablation was 30 watts with an average temperature of 70 degrees celsius.The total duration of rf application was unknown, but "many" applications were made (more than 20).After more than 15 attempts, there were high impedance errors which prevented the delivery of rf (impedance was above 200 ohms).It was not determined what had been causing the high impedance.During the last ablation, a ventricular fibrillation (vf) occurred.The patient required cardioversion and the vf stopped, but there was no heart rhythm.The heart was stimulated via the his catheter and after a few seconds of stimulation, the heart began to work again and came back to sinus rhythm.Due to this complication, the physician decided to end the procedure and all catheters were removed.The patient was awake and lucid at that time.Equipment was disconnected and the patient was being prepared for transfer to an observation room.While attempting to move the patient from his bed to a stretcher, he lost consciousness due to a new vf event.The patient was again cardioverted and returned to sinus rhythm.A chest x-ray was taken and pericardial effusion was noted.The patient again had several vf events and was cardioverted each time; in some cases, the heart didn't return to sinus rhythm.A temporary pacemaker was implanted; however, the heart was not responding to stimulation.Cardiac massage was done, but the patient went back into vf and required cardioversion.Due to the perforation, a heart surgeon was called.He opened the patient's chest but was not able to do anything; after several minutes it was decided to stop and the patient was pronounced dead.The official cause of death was not reported.It was reported that the cause of the vf was not determined, but that the vf was not caused by the dynamic xt.The cause of the effusion was not determined, but the perforation was "most likely" caused by the ablation catheter.The procedure itself was also noted as a potential contributing factor.

• Brand Name: DYNAMIC XT
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; dc a330,; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora,; heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 7742186
• MDR Text Key: 115789897
• Report Number: 2134265-2018-60009
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: 08714729877615
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K921872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2021
• Device Model Number: 86706
• Device Catalogue Number: 86706
• Device Lot Number: 0022133639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABLATION CATHETER: BIOSENSE WEBSTER SMARTTOUCH; DEFLECTABLE DIAGNOSTIC CATHETER: BIOSENSE WEBSTER; GENERATOR: BIOSENSE WEBSTER SMARTABLATE; MAPPING SYSTEM: BIOSENSE WEBSTER CARTO
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 58 YR