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

Model Number 87035

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

Patient Problems Stroke/CVA (1770); Ruptured Aneurysm (4436)

Event Date 12/13/2023

Event Type  Death  

Event Description

It was reported that during an ablation procedure to treat atrial fibrillation an intellamap orion high resolution mapping catheter was selected for use.Due to a possible cerebral aneurysm the patient's blood pressure fluctuated wildly 7 hours into the procedure, about an hour before the procedure ended.At that time, the cerebral aneurysm ruptured, resulting in cerebral hemorrhage.X-ray imaging was used.The procedure was completed with no patient complications.The patient's level of consciousness did not return after the cerebral hemorrhage.The device is not expected to be returned for analysis due to disposal.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during an ablation procedure to treat atrial fibrillation an intellamap orion high resolution mapping catheter was selected for use.Due to a possible cerebral aneurysm the patient's blood pressure fluctuated wildly 7 hours into the procedure, about an hour before the procedure ended.At that time, the cerebral aneurysm ruptured, resulting in cerebral hemorrhage.X-ray imaging was used.The procedure was completed with no patient complications.The patient's level of consciousness did not return after the cerebral hemorrhage.The device is not expected to be returned for analysis due to disposal.It was further reported the procedure was performed on uninterrupted anticoagulation regimen.The activated clotting time (act) for the patient was 300, and about seven hours passed between the initial act and last act recorded.Computed tomography (ct) and intracardiac echocardiography (ice) scans were performed to rule out thrombus pre-procedure.No clot was found during the procedure.The irrigation flow rate from the pump was 17 ml/min at or below 30w and 30 ml/min above 30w.The patient died two days after the procedure.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during an ablation procedure to treat atrial fibrillation an intellamap orion high resolution mapping catheter was selected for use.Due to a possible cerebral aneurysm the patient's blood pressure fluctuated wildly 7 hours into the procedure, about an hour before the procedure ended.At that time, the cerebral aneurysm ruptured, resulting in cerebral hemorrhage.X-ray imaging was used.The procedure was completed with no patient complications.The patient's level of consciousness did not return after the cerebral hemorrhage.The device is not expected to be returned for analysis due to disposal.It was further reported the procedure was performed on uninterrupted anticoagulation regimen.The activated clotting time (act) for the patient was 300, and about seven hours passed between the initial act and last act recorded.Computed tomography (ct) and intracardiac echocardiography (ice) scans were performed to rule out thrombus pre-procedure.No clot was found during the procedure.The irrigation flow rate from the pump was 17 ml/min at or below 30w and 30 ml/min above 30w.The patient died two days later.It was further reported the official cause of death was cerebral hemorrhage.No autopsy of the patient was performed.

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 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: 18373489
• MDR Text Key: 331112663
• Report Number: 2124215-2023-71412
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2024

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 Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0032343560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 12/20/2023; 12/25/2023
• Supplement Dates FDA Received: 12/27/2023; 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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
• Patient Outcome(s): Death; Life Threatening
• Patient Sex: Female