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 M004PM4790N40

Device Problems Kinked (1339); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 17sep2014.It was reported that catheter shaft kink and a sensor failure occurred.A intellatip mifi xp temperature ablation catheter 7/110/2.5/8-10 n4 was selected to treat the right atrium.During the procedure, it was noted that the distal end of the catheter kinked and a d06 error was identified indicating a sensor failure.The procedure was completed with a different device.There were no patient complications reported and the patient¿s condition was good.However, device analysis revealed broken adhesive at ring 1 and fluids residues under the adhesive of all the rings and dry residues over the ring.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Unit returned in a generic plastic bag.The unit returned has the distal end kinked, as part of overall visual revision.The returned device matches with upn and lot provided by the customer.The device has a kink at the distal section while in the neutral position at 1.3cm from the tip.In addition the device has a broken adhesive at ring 1 and fluids residues under the adhesive of all the rings and dry residues over the ring 3.The rings damage location match with kink location.The ablation was verified by using the maestro generator 3000, and the device was found within specification.Electrical test was performed and the device was found within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(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: 4169814
• MDR Text Key: 16175116
• Report Number: 2134265-2014-06069
• Device Sequence Number: 1
• Product Code: OAD
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2017
• Device Model Number: M004PM4790N40
• Device Catalogue Number: PM4790N4
• Device Lot Number: 16818653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• 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