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	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported that the patient experienced a cardiac tamponade and effusion.During an ablation procedure to treat atrial tachycardia, after placing the catheters in the coronary sinus (cs), "hra", "his", right ventricle (rv) and "halo," mapping was performed with an intellamap orion catheter, and radiofrequency (rf) ablation was performed using an intellanav mifi open-irrigated ablation catheter.A blazer dx catheter was placed right atrium ventricular free-wall side, and underwent an electrophysiology study (eps).Four other non-boston scientific catheters were also used during the procedure.After the procedure, when the intellanav mifi open-irrigated ablation catheter was completely pulled out from the patient's body, and hemostasis was performed at the groin, the patient's blood pressure dropped rapidly.A cardiac tamponade was observed by echocardiogram, so pericardial drainage was performed.Although the physician did not know the cause of the effusion, there was possibility that perforation might have been caused because the atrial wall on ablation site was thin.It was unknown which catheter caused or contributed to the event.No resistance was felt while maneuvering the catheters.

• 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: 9410676
• Report Number: 2134265-2019-14920
• Device Sequence Number: 11221237
• Product Code: DRF
• UDI-Device Identifier: 08714729780519
• UDI-Public: 08714729780519
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 03/24/2022
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0023536994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 12/04/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLAMAP ORION CATHETER; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR