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 M004PM4790K20

Device Problems Bent (1059); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer - unit returned in a generic plastic bag.Visual inspection revealed the device has a slight kink at 14mm from the tip while in the neutral position (between ring 1 and 2).In addition, the device has broken adhesive on ring #2 and fluids under it.Finally, the distal end is kinked at 3cm from the tip.X ray analysis revealed that the center support is broken.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).

Event Description

Reportable based on device analysis completed on (b)(6) 2016.It was reported that a kink and deformed curve occurred.Radiofrequency catheter ablation was performed with a intellatip mifi¿ xp temperature ablation catheter.During use, it was noted that the curved shaft was slightly kinked and deformed.No patient complications were reported and the patient's current condition is good.

• 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: 5576418
• MDR Text Key: 42700260
• Report Number: 2134265-2016-02665
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2017
• Device Model Number: M004PM4790K20
• Device Catalogue Number: PM4790K2
• Device Lot Number: 17513336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2014
• 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