MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLATIP MIFI XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 87163

Device Problem Noise, Audible (3273)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/07/2021

Event Type  Injury  

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.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

Event Description

During a cavo-tricuspid isthmus (cti) line ablation procedure to treat atrial fibrillation a intellatip mifi xp catheter was selected for use.The system was operating at default settings and the temperature control was at 70 watts and 65 degrees.After cti block was confirmed, it was reported that a steam pop occurred during the extra ablation inside the cti inferior vena cava.Cardiac tamponade was also observed.The procedure was completed with treatment.

• Brand Name: INTELLATIP MIFI XP
• 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: 12747290
• MDR Text Key: 279951200
• Report Number: 2134265-2021-13844
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729848059
• UDI-Public: 08714729848059
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2021

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: 05/18/2024
• Device Model Number: 87163
• Device Catalogue Number: 87163
• Device Lot Number: 0027342289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other