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 M004PM4500K20

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was returned for analysis.A visual examination of the returned device revealed a kink 14 mm from the tip while in the neutral position (between ring 1 and 2).In addition the ring #1 and #2 have broken adhesive and fluids under them.The steering knob and the tension control knob functioned properly on both lock and unlock positions.Both curves are placed in the template shaded area.The device passed the dimensional test.As per x ray image, it revealed that the center support is kinked.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause of this complaint is operational context, since it is most likely that due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on 19nov2015.It was reported that the tip of catheter was deformed.A 7/110/2.5/8-8 intellatip mifi xp temperature ablation catheter was selected for use.When the physician pulled the device out from the packaging, it was noticed that the tip of the catheter was deformed.There was a kink in the tip of the catheter.The procedure was completed with another of the same device.The device never went inside the patient's body no patient complications were reported.However,device analysis revealed that the device has broken adhesive on the ring #1, #2.

• 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: 5285464
• MDR Text Key: 33151363
• Report Number: 2134265-2015-08473
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2015

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: 06/02/2018
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 18056011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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