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 Loss of consciousness (2418); Confusion/ Disorientation (2553)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

Weight: (b)(6).

Event Description

(b)(6).It was reported that the patient experienced unresponsiveness and acute confusion.During an ablation procedure, an intellamap orion catheter was selected for use.During the procedure, the patient became poorly responsive and was unable to answer questions.The sedation/analgesia was reversed, but then the patient was acutely confused/agitated.The procedure was abandoned.The suspected cause was confusion secondary to sedation/analgesia.An intracranial event (bleed or thromboembolic event) was also suspected, but no evidence of this was shown on a head computerized tomography (ct).The outcome of the event was not recovered/not resolved.The event was unlikely related to study device, not related to non-study device or non-study accessories and a casual relationship to the study procedure.

• 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: 8226273
• MDR Text Key: 132358582
• Report Number: 2134265-2018-64897
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2019
• Device Model Number: M004RC64S0
• Device Catalogue Number: 87035
• Device Lot Number: 0022319653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR