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 M004EPM4500K20

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Device evaluated by mfr: the catheter was received for analysis after decontamination.The returned device matches the upn and lot number provided by the customer.Visual inspection found a kink in the device approximately 13mm from the distal tip in the neutral position between r1 and r2.The ring 1 and ring 2 seals were found to be compromised; there is body fluid on the edge of the rings.Functional inspection found the steering knob and the tension control knob functioned properly on both lock and unlock positions.The catheter was placed on the curve template and the device passed both right and left curves tests.However, the device has a kink at the distal section at approximately 13mm from the tip.The distal section of the catheter was dissected.A small amount of body fluid was found in the interior of the sheath.The kevlar wrap was displaced and the center support was bent.One of the steering wires was detached, and there was evidence of solder on both the center support and the detached steering wire.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Complaint confirmed.The most probable root cause of the reported difficulty is a design constraint of the product.(b)(4).

Event Description

Reportable based on device analysis completed on 01mar2017.It was reported that catheter deformation occurred.During a ep study inside the patients anatomy it was noted that the distal shaft of the intellatip mifi¿ xp temperature ablation catheter was deformed with humps which limited the maneuverability of the catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient status is stable.However device analysis found ring 1 and ring 2 seals to be compromised.Dried body fluid was found on the edge of the rings, and in the interior of the sheath.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6408884
• MDR Text Key: 70065898
• Report Number: 2134265-2017-02130
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: M004EPM4500K20
• Device Catalogue Number: EPM4500K2
• Device Lot Number: 18967904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2016
• 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