MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER¿ DX-20 CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M00420SL5550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer ¿ the device was not returned; 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.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
It was reported a pericardial effusion occurred.A blazer¿ dx-20 diagnostic catheter was selected for use during an atrial fibrillation and atrial flutter ablation procedure.A quad catheter, intracardiac echocardiography (ice) catheter, ablation catheter, two sheaths, and a transseptal needle from other manufacturers were also selected for use.The quad catheter was placed in the right ventricle, and the blazer dx-20 catheter was placed in the right atrium with the distal portion in the coronary sinus.The ice catheter was also placed in the right atrium.A sheath and needle were used for transseptal access; due to the patient¿s rotated anatomy and low fossa ovalis, the physician had difficulty gaining access to the left atrium (la).La access was gained; the ablation catheter was inserted through the sheath and some la anatomy was created.The sheath was exchanged for a sheath from a different manufacturer, when a drop in blood pressure was noticed and a pericardial effusion was observed by the ice catheter.A pericardial drain was placed.All catheters were then removed from the heart.Minimal effusion was evident when the patient left the room in stable condition.The physician indicated the cause of the effusion was ¿most likely¿ the transseptal needle and none of the diagnostic catheters or sheaths.There were no performance issues with the device.

• Brand Name: BLAZER¿ DX-20 CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7540592
• Report Number: 2134265-2018-04775
• Device Sequence Number: 19298078
• Product Code: DRF
• UDI-Device Identifier: 08714729780496
• UDI-Public: 08714729780496
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K081576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: 02/20/2021
• Device Model Number: M00420SL5550
• Device Catalogue Number: 20SL555
• Device Lot Number: 0021772019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABLATION CATHETER: ST. JUDE TACTICATH; ICE CATHETER: BIOSENSE WEBSTER ACUNAV; SHEATH: MEDTRONIC FLEXCATH; SHEATH: ST. JUDE AGILIS NXT
• Outcome Attributed to Adverse Event: Required Intervention