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 Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Weakness (2145)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight: (b)(6).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

(b)(6) clinical study.It was reported that a patient experienced hypertension, weakness and dyspnea.An ablation procedure was performed with an intellanav mifi open-irrigated catheter.The patient was noted to have hypertension; blood pressure (bp) was 166/87.The patient noted the high bp when feeling weak and had shortness of breath (sob) with exertion.The patient was given metoprolol 50 mg early for their bp and was switched to toprol xl 50 mg the next day.It was decided to keep patient for an extra night of observation due to the issues.The suspected cause was unknown.The outcome of the event was not resolved.

• 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 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: 8915482
• MDR Text Key: 155041594
• Report Number: 2134265-2019-10065
• 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: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2019

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: 10/21/2020
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0023675587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: INTELLANAV MIFI OPEN-IRRIGATED
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR