MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

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

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); ST Segment Elevation (2059); Cardiac Tamponade (2226)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

Same case as 2134265-2018-62829.It was reported arrhythmia, st elevation, cardiac arrest, and tamponade occurred.An intellamap orion mapping catheter and an intellanav mifi oi were selected for use during a pulmonary vein isolation (pvi) re-do procedure.While mapping in the left atrium with the orion in a steerable sheath, the physician detected abnormalities in the patient's blood pressure.Mapping was discontinued and the patient was monitored for approximately 20 minutes.An ultrasound was used to determine whether a pericardial puncture had occurred; the ultrasound revealed a small abnormality.The patient was in stable condition and a decision was made to end the procedure.No ablation took place.Within 10 minutes of removing all catheters and sheaths, the patient displayed alarming changes in heart rate, rhythm, and blood pressure.An st elevation occurred and emergency personnel were contacted.A moment later, the patient's heart stopped.The patient was successfully reanimated, cardiac tamponade was detected, a pericardiocentesis was performed, and the patient was in stable sinus rhythm approximately 30 minutes to 1 hour after the st elevation first occurred.The patient was in stable condition at the last update, approximately 4 hours after the procedure ended.It was unclear how the tamponade occurred.The only unusual aspect of this routine procedure was that the mapping catheter was briefly placed in the appendage in an undeployed state.The physician suspected that this may have caused a pericardial puncture and subsequent tamponade.The physician did not report feeling any resistance during the case.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; 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: 8074825
• MDR Text Key: 127278231
• Report Number: 2134265-2018-62834
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K143481
• 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: 11/15/2018

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: 05/17/2019
• Device Model Number: M004RC64S0
• Device Catalogue Number: 87035
• Device Lot Number: 0022134295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ABLATION CATHETER: INTELLANAV MIFI OI; CS CATHETER: ABBOTT INQUIRY, 6F; SHEATH: ABBOTT 407451 SLO BLACK BRAOIDED; SHEATH: ABBOTT AGILIS 408310, 71CM
• Patient Outcome(s): Life Threatening; Other; Required Intervention