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

Model Number 87047

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during a typical atrial flutter ablation procedure with a intellanav mifi open-irrigated catheter a fluid leak was observed.The catheter was used successfully for most of the case (2 hours).However, flushing the catheter prior to insertion into patient for third time revealed the fluid leak and catheter was abandoned.The catheter was replaced and the procedure was completed.No patient complications were reported.

Manufacturer Narrative

The luer and irrigation tubing was cracked and torn at the proximal (narrowest) side of the adhesive joint securing the tubing to the luer fitting.Dried body fluid found on the luer tube and handle.Electrical continuity checks revealed no electrical opens or shorts, all electrode/ thermocouple/magnetic sensor resistances measured in spec and were typical.The measurements were repeated in the right and left curve configuration and again, all measurements were within specifications and typical.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that during a typical atrial flutter ablation procedure with a intellanav mifi open-irrigated catheter a fluid leak was observed.The catheter was used successfully for most of the case (2 hours).However, flushing the catheter prior to insertion into patient for third time revealed the fluid leak and catheter was abandoned.The catheter was replaced and the procedure was completed.No patient complications were reported.It was further reported that no error messages were observed.The leak was observed while preparing the catheter outside of the patient.Another catheter of the same type was used to complete the procedure successfully.

Event Description

It was reported that during a typical atrial flutter ablation procedure with a intellanav mifi open-irrigated catheter a fluid leak was observed.The catheter was used successfully for most of the case (2 hours).However, flushing the catheter prior to insertion into patient for third time revealed the fluid leak and catheter was abandoned.The catheter was replaced and the procedure was completed.No patient complications were reported.It was further reported that no error messages were observed.The leak was observed while preparing the catheter outside of the patient.Another catheter of the same type was used to complete the procedure successfully.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• 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
• MDR Report Key: 11065056
• MDR Text Key: 223402464
• Report Number: 2134265-2020-18395
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (y/n): N
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0025014590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Date Manufacturer Received: 02/22/2021
• Patient Sequence Number: 1
• Patient Age: 62 YR