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

Model Number M004PM47900

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2015

Event Type  malfunction  

Event Description

Reportable based on additional information received on 19mar2015.It was reported that during a ablation procedure, tip damage occurred.The target lesion was located in the right atrium.As the physician was manipulating the 7/110/2.5/8-10 std intellatip mifi¿ xp temperature ablation catheter it was noted that the catheter appeared to be at a strange angle.The catheter was removed from the patient and it was found that the curve shape of the catheter tip was unusual.No patient complications were reported and the patient status is good.However analysis revealed that the adhesive between the electrodes was broken.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4) - the device has broken adhesive on ring #1 and has fluids under it.The steering knob and the tension control knob functioned properly on both lock and unlock positions.The right and left curves are not placed in the template shaded areas, the device failed the dimensional test.The device was dissected finding the center support broken at 17mm from the tip.The center support was sent to the mtac laboratory to determine the failure mode, the the center support presented evidence of cyclic reverse bending overload as failure mode.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

• Brand Name: INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4685296
• MDR Text Key: 5711795
• Report Number: 2134265-2015-02064
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2017
• Device Model Number: M004PM47900
• Device Catalogue Number: PM4790
• Device Lot Number: 0017516717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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