MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER DX-20; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced hypotension.During an ablation procedure for atrial flutter, a blazer dx-20 catheter was inserted in the patient with no issues.Then, an intellamap orion catheter was inserted into the patient with no issues.About 5 minutes later, the patient's blood pressure dropped.They had to do compressions and then the patient's pressure was fine.The case was then cancelled.The doctor checked with ultrasound to check if there was an effusion from the catheters and there was not.The physician believed that the event was due an anesthesia issue and not the devices.The patient was fine and there were no other complications.
Event or Problem Description
It was reported that the patient experienced hypotension.During an ablation procedure for atrial flutter, a blazer dx-20 catheter was inserted in the patient with no issues.Then, an intellamap orion catheter was inserted into the patient with no issues.About 5 minutes later, the patient's blood pressure dropped.They had to do compressions and then the patient's pressure was fine.The case was then cancelled.The doctor checked with ultrasound to check if there was an effusion from the catheters and there was not.The physician believed that the event was due an anesthesia issue and not the devices.The patient was fine and there were no other complications.It was further reported that the "compressions" meant the patient required cardiopulmonary resuscitation (cpr).
Additional Manufacturer Narrative
The device was returned for analysis.The device did not have visual defects.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.The right and left curves are placed in the template shaded areas, the device passed the dimensional test.The electrical test was performed and the device was found within specification.No opens or shorts were found.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: BLAZER DX-20
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8691221
• Report Number: 2134265-2019-06810
• Device Sequence Number: 1643934
• Product Code: DRF
• UDI-Device Identifier: 08714729780526
• UDI-Public: 08714729780526
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K081576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2021
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0022394519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/11/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLAMAP ORION CATHETER; INTELLAMAP ORION CATHETER; INTELLAMAP ORION CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 70 YR