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 Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient age: over 18 years old.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 provided by the customer.The device has a kink at 14mm from the tip while in the neutral position (between ring 1 and 2).In addition the ring #1 has broken adhesive and fluids under.As per x ray image attached, 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 is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable upon analysis completed on 08dec2015.It was reported that during a radiofrequency catheter ablation of the tricuspid valve--inferior vena cava isthmus, after ablation was performed twice in the intracardiac cavity, the curve section got bent when changing the curve.There was no issue noted to the curve when the device was visually checked prior to insertion.The procedure was completed with another of the same device.Patient status is listed as good.Device analysis found broken adhesive.

• 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: 5348970
• MDR Text Key: 35207486
• Report Number: 2134265-2015-09244
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2015

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: 07/02/2018
• Device Model Number: M004PM4790N40
• Device Catalogue Number: PM4790N4
• Device Lot Number: 18159904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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