MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLAMAP ORION¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

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

Patient Problems Cardiac Arrest (1762); Cardiogenic Shock (2262)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id# 2134265-2018-01862, 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.

Manufacturer Narrative

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.There is a kink approximately 4.5 cm from the distal tip.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).

Event Description

Same case as mdr id# 2134265-2018-01862, 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.

• Brand Name: INTELLAMAP ORION¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7316071
• MDR Text Key: 101581960
• Report Number: 2134265-2018-01863
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2018
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 21279762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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 SF
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 66 YR