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	Congestive Heart Failure (1783); Dyspnea (1816); Weakness (2145)
Date of Event	02/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: (b)(6).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 or Problem Description
(b)(6) clinical study.It was reported the patient experienced acute diastolic congestive heart failure (chf).Three days following an ablation procedure with an intellanav mifi open-irrigated catheter, a blazer dx-20 and an intellamap orion high resolution mapping catheter, the patient went to the hospital for shortness of breath on exertion and weakness.The suspected cause was acute diastolic congestive heart failure.Lasix was added to the patient's oral medication treatment and the event resolved.

• Brand Name: BLAZER DX-20
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10046568
• Report Number: 2134265-2020-06326
• Device Sequence Number: 19656449
• Product Code: DRF
• UDI-Device Identifier: 08714729780526
• UDI-Public: 08714729780526
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K081576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

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: 12/12/2022
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0024906632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/12/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; INTELLANAV MIFI OPEN-IRRIGATED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR