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

Model Number	87070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: (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
It was reported that during an ablation procedure involving a intellanav mifi open-irrigated ablation catheter, three viking electrode catheters, and an dynamic xt catheter, the patient experienced tamponade.The event required invasive intervention to resolve and prolongation of hospitalization, however the details of the intervention were not specified.No further patient complications were reported.The devices are not expected to be returned to boston scientific for analysis.
Additional Manufacturer Narrative
Date of birth: 1976.Updated coding to include f12: serious injury/ illness / impairment.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 during an ablation procedure involving a intellanav mifi open-irrigated ablation catheter, three viking electrode catheters, and an dynamic xt catheter, the patient experienced tamponade.The event required invasive intervention to resolve and prolongation of hospitalization, however the details of the intervention were not specified.No further patient complications were reported.The devices are not expected to be returned to boston scientific for analysis.

• Brand Name: VIKING
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12920712
• Report Number: 2134265-2021-15275
• Device Sequence Number: 14701066
• Product Code: DRF
• UDI-Device Identifier: 08714729878070
• UDI-Public: 08714729878070
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K971265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: 06/29/2023
• Device Model Number: 87070
• Device Catalogue Number: 87070
• Device Lot Number: 0027582502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DYNAMIC XT CATHETER; DYNAMIC XT CATHETER; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; VIKING ELECTRODE CATHETER; VIKING ELECTRODE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female