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 Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: unit returned in a generic plastic bag.The unit returned has 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 13mm from the tip while in the neutral position (between ring 1 and 2).In addition the rings #1 and #2 has broken adhesive and 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 placed in the template shaded areas, the device passed the dimensional test.However, the device has a kink at the distal section.As per x ray image, the center support is kink.Complaint confirmed, the returned device has a kink at the distal section while in the neutral position, however, the device passed the curve dimensional test.As per x ray image, the center support was found kinked.In addition, the device has broken adhesive on tip and the rings #1 and #2 and fluids under them.The ring damage location match with kink location, so the adhesive probably broke due to the kink.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

Complaint reportable upon analysis completed on (b)(6) 2015.It was a reported that the steering wire broke.The lesion being treated was located in the right atrium.While using intellatip mifi¿ xp temperature ablation catheter it was noted that steering wire broke and the catheter could no longer deflect beyond the 2-3 bipole.The device was successfully removed and the procedure was completed with another device.No patient complications were reported and the patient's status is fine.Device analysis revealed lifted electrodes.

• 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: 5083757
• MDR Text Key: 26016033
• Report Number: 2134265-2015-06228
• 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
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2018
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 17554453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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