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

Model Number M004PM45000

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2015.It was reported that the curve section of the device was bent.The target lesion was located in the coronary artery.A 7/11/2.5/8-8 intellatip mifi¿ xp temperature ablation catheter was selected and advanced to treat the target lesion.During the ablation procedure in the inferior vena cava to the tricuspid annulus, it was noted that the curve section of the device was bent.The device was removed from the patient.The procedure was completed with another of the same device.No patient complications reported and the patient's status was good.However, returned device analysis revealed a broken adhesive on ring #1 and #2.

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.A visual inspection revealed that the device has a broken adhesive on ring#1 and #2 besides has a fluids under them.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 handle was opened, and no issues were detected in that section.The device was dissected and the guide coil was inspected finding no issues on it.The distal section was dissected finding the center support broken at 13 mm from the tip.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 (HEREDIA); 302 parkway; la aurora; heredia ; 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: 4859676
• MDR Text Key: 18658036
• Report Number: 2134265-2015-03676
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2017
• Device Model Number: M004PM45000
• Device Catalogue Number: PM4500
• Device Lot Number: 0017294665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2014
• 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
• Treatment: GENERATOR: MAESTRO 3000