MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86736
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vaso-Vagal Response (2661); Pericardial Effusion (3271)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: (b)(6) 2019 tacticath contact force ablation catheter, sensor enabled.Abbott complaint number: (b)(4).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 a patient experienced a pericardial effusion and a vasovagal response.During a ventricular contraction ablation procedure, a pericardial effusion occurred.Following ablation on the basal septal wall of the left ventricular, the patient experienced a vagal response.An effusion was confirmed by echocardiogram and was thought to be located from the apex of the left ventricle (lv).Protamine sulfate was used to reverse the effects of heparin.The patient was stable following the procedure.The physician alleged the effusion to the ablation catheter, but could not be sure.

• Brand Name: DYNAMIC XT
• 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: 8936392
• Report Number: 2134265-2019-10309
• Device Sequence Number: 439358
• Product Code: DRF
• UDI-Device Identifier: 08714729879893
• UDI-Public: 08714729879893
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K921872
• 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): 08/27/2019

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: 04/28/2022
• Device Model Number: 86736
• Device Catalogue Number: 86736
• Device Lot Number: 0023602732
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention