MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 87047

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/19/2021

Event Type  Injury  

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 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.

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 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: INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 12920722
• MDR Text Key: 281653600
• Report Number: 2134265-2021-15269
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0027872822
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DYNAMIC XT; DYNAMIC XT; VIKING ELECTRODE CATHETER; VIKING ELECTRODE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Sex: Female