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 M004PMR9620K20

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer - visual inspection reveled the luer fitting is cracked.Dried body fluid was found under the proximal ring 3 seal and under the proximal edges of ring 1 & 3 electrodes.Dried body fluid also found on the handle, main body and distal end.Dried saline was found on the distal end an inside the irrigation holes.Electrical continuity checks revealed no electrical shorts, as checked manually using a multi-meter and breakout box.Ring 3 was electrically open.All other electrodes, sensor and thermocouple resistances measured in spec and were typical.Lcr test was performed and confirmed that the magnetic sensor was within specifications.The device passed tip offset measurement test.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.X-ray found dried body fluid between rings 1 & 2.No other anomalies were found.Distal end was dissected to examine the ring 3 wire and electrode.Ring 3 electrode wire was broken at the ankle to the electrode.Dried body fluid found under all 3 rings and electrode wire holes.The manufacturing batch record review confirmed that 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

Same case as same case as mdr id # 2134265-2018-07493.Reportable based on analysis completed on 11oct2018.It was reported that during an ablation procedure with two intellanav mifi open-irrigated ablation catheters the first catheter noise was observed.The catheter was replaced with another catheter and its virtual image move and disappear while rf energy was applied.No patient complications were reported.However; returned device analysis revealed body fluid ingress.

• 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: 7999206
• MDR Text Key: 124813038
• Report Number: 2134265-2018-07492
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2020
• Device Model Number: M004PMR9620K20
• Device Catalogue Number: PMR9620K2
• Device Lot Number: 0021836647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2018
• 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