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 Problem Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: visual inspection showed that the luer fitting is cracked.The ring 1 proximal seal is damaged and a chunk of distal end tubing is missing at the distal tip bond.Dried body fluids were also found on the handle, main body tubing and distal end.Dried saline found on the distal tip and inside the irrigation holes.Body fluids were found on the handle and main body tubing.Continuity checks revealed no electrical opens or shorts, as checked manually using a multi-meter and breakout box.All electrode, sensor and thermocouple resistances measured in spec and were typical.Functional inspection 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.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Same case as: 2134265-2018-06236.Reportable based on device analysis completed on (b)(6) 2018.It was reported that catheter kinking and signal loss occurred.A intellanav mifi open-irrigated ablation catheter was selected for a ventricular tachycardia ablation.However the catheter had an abnormal bend so that the physician couldn't work with it.The catheter was replaced with a second intellanav mifi open-irrigated.The direct sense interfaces disappeared on the second catheter and the option to enable it again was gone, restarting the study didn't help so the physician decided to ablate without direct sense.For troubleshooting reasons we changed short before the end of the procedure again the catheter to see if the problem is software related or catheter related, we saw that the direct sense features came back with the use of another of the same catheter.No patient complications were reported however; returned device analysis reveled distal end with seal and tubing damage.

Event Description

Same case as: 2134265-2018-06236.Reportable based on device analysis completed on 20june2018.It was reported that catheter kinking and signal loss occurred.A intellanav mifi open-irrigated ablation catheter was selected for a ventricular tachycardia ablation.However the catheter had an abnormal bend so that the physician couldn't work with it.The catheter was replaced with a second intellanav mifi open-irrigated.The direct sense interfaces disappeared on the second catheter and the option to enable it again was gone, restarting the study didn't help so the physician decided to ablate without direct sense.For troubleshooting reasons we changed short before the end of the procedure again the catheter to see if the problem is software related or catheter related, we saw that the direct sense features came back with the use of another of the same catheter.No patient complications were reported however; returned device analysis reveled distal end with seal and tubing damage.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: further analysis revealed that this device was one of eight devices from lot 21583857 which were mistakenly programmed as a us model.The complaint site for this device was ous.Us programmed devices are not compatible with ous enabled direct sense modules.The investigation conclusion is supplier manufacturing process design as the design or validation of a suppliers manufacturing process was not sufficient to ensure the finished device met the intent of the design.(b)(4).

• 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
• MDR Report Key: 7681154
• MDR Text Key: 113758149
• Report Number: 2134265-2018-06363
• 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
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2020
• Device Model Number: M004EPMR9620K20
• Device Catalogue Number: EPMR9620K2
• Device Lot Number: 21583857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Date Manufacturer Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1