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

Model Number M004MR45000

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the catheter was received for analysis after decontamination (in appropriate packaging).The returned device matches the upn and lot number provided by the customer.Body fluid was found under the seal of ring 3.A small piece of blue foreign material was found imbedded in the catheter.Electrical continuity checks revealed no shorts as checked manually using a multi-meter and breakout box.The tip was found to be open.An lcr test was performed which confirmed that the sensor measured within specifications.Functional inspection found 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 device was connected to the maestro and the hi impedance message was displayed.X-rays did not reveal any abnormalities in the handle or the distal end.Collapsed guide coil under the strain relief was noted however.Dissection was performed.Measurements after dissection showed that the open of the tip wire was located inside the tip itself.There was continuity between the tip wire just proximal of the tip body to the handle connector.The tip was mounted on a chuck and was parallel polished.Parallel polishing found that the tip wire was fractured near the distal tip¿s proximal edge.Further attempts to determine the fracture surface features were unsuccessful.The fracture was buried in an area where, if accessed, would damage/alter the integrity of the fracture surface features.Insulation was dissected further around ring 3 to determine if bodily fluid ingress was present.No bodily fluid was observed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specification.Complaint confirmed.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that high impedance occurred.The physician was unable to ablate due to a high impedance warning.The procedure was completed using another of the same catheter with no patient complications.However, device analysis found foreign matter and body fluid under the seal of ring 3.

• Brand Name: INTELLANAV¿ MIFI XP TEMPERATURE 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: 6962413
• MDR Text Key: 90647888
• Report Number: 2134265-2017-10603
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729885719
• UDI-Public: 08714729885719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020025
• 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: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/18/2019
• Device Model Number: M004MR45000
• Device Catalogue Number: MR4500
• Device Lot Number: 0019984171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR