BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLAMAP ORION¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number M004RC64S0 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Cardiogenic Shock (2262)
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Event Date 02/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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Same case as mdr id# 2134265-2018-01863, 2134265-2018-01864, and 2134265-2018-01976.It was reported cardiac arrest and cardiogenic shock occurred.Two intellamap orion mapping catheters, a dynamic xt steerable diagnostic catheter, and a woven diagnostic catheter were selected for use during a ventricular tachycardia ablation procedure.During ablation with another manufacturer¿s ablation catheter, the patient experienced cardiac arrest and cardiogenic shock.Multiple external defibrillations/shocks were administered, as well as advanced life support including cpr and medications.The patient ultimately received circulatory assist devices (a heart pump and extracorporeal membrane oxygenation (ecmo)) before being transferred from the ep lab.The ep staff later reported that the patient required vascular surgery the next day as a result of the ecmo device.The patient appeared to be stabilized but in critical condition.Noise with the orion catheters had been noted; however, there was no information alleging the noise caused or contributed to the complications.The orion catheters had been removed from the patient¿s body for two and a half hours prior to onset of the patient¿s complications.The dynamic xt was in the patient when the complications occurred, and the woven catheter was positioned in the right ventricle thorough out the procedure.The physician was uncertain as to the cause of the cardiac arrest and cariogenic shock, but commented that the patient was likely sicker than previously considered prior to the procedure.
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Manufacturer Narrative
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Device evaluated by mfr: visual inspection of the returned device revealed evidence of damage to the proximal end of the basket on splines 1 through 8 from what appears to be trimming / cutting of adhesive around the collar, leading to a failure of the row 7 and 8 electrodes.Electrical testing was performed and the device failed the test.The magnetic sensor resistance and inductance measurements were within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).
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Event Description
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Same case as mdr id# 2134265-2018-01863, 2134265-2018-01864, and 2134265-2018-01976.It was reported cardiac arrest and cardiogenic shock occurred.Two intellamap orion mapping catheters, a dynamic xt steerable diagnostic catheter, and a woven diagnostic catheter were selected for use during a ventricular tachycardia ablation procedure.During ablation with another manufacturer¿s ablation catheter, the patient experienced cardiac arrest and cardiogenic shock.Multiple external defibrillations/shocks were administered, as well as advanced life support including cpr and medications.The patient ultimately received circulatory assist devices (a heart pump and extracorporeal membrane oxygenation (ecmo)) before being transferred from the ep lab.The ep staff later reported that the patient required vascular surgery the next day as a result of the ecmo device.The patient appeared to be stabilized but in critical condition.Noise with the orion catheters had been noted; however, there was no information alleging the noise caused or contributed to the complications.The orion catheters had been removed from the patient¿s body for two and a half hours prior to onset of the patient¿s complications.The dynamic xt was in the patient when the complications occurred, and the woven catheter was positioned in the right ventricle thorough out the procedure.The physician was uncertain as to the cause of the cardiac arrest and cariogenic shock, but commented that the patient was likely sicker than previously considered prior to the procedure.
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