MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004EPMR9620K20

Device Problems Bent (1059); No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: visual inspection revealed that the distal end was bent to the right.The seal to ring 1 appeared to be compromised and body fluid was present along the distal edge of the electrode.There was also dried body fluid on the luer, handle, and shaft.Electrical testing revealed no shorts, however the magnetic sensor was found to be open in all curve configurations.X-ray showed a bent center support.Functional inspection, rf ablation testing, and dissection revealed no anomalies.The manufacturing batch record review confirmed the device met all material, assembly, and performance specifications.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).

Event Description

This event is reportable based on device analysis completed on 4/4/18.While in the right ventricle, during ablation of ventricular tachycardia, the intellanav mifi catheter disappeared from the screen; no error messages were displayed.The curve of the catheter also looked deformed on x-ray.The catheter was removed from the patient to visually check the curve and at this time, no directsense data was displayed.Disconnecting the catheter and restarting the study did not resolve the issue.The catheter was replaced in order to complete the procedure, and no patient complications occurred.Device analysis revealed a compromised seal on ring 1.

• 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 - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7482563
• MDR Text Key: 107201848
• Report Number: 2134265-2018-03642
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P150005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2019
• Device Model Number: M004EPMR9620K20
• Device Catalogue Number: EPMR9620K2
• Device Lot Number: 20687026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1