MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER PRIME¿ XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004EPTP4500THN40

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the device revealed that the shaft is bent at 90 degrees at approximately 1.8cm from the distal tip between ring 2 and ring 3.An end edge of the center support is poking out of the tubing at the bend.Both the ring 2 and ring 3 seals are compromised.Continuity checks revealed no electrical opens or shorts and all electrode, thermistor and sensor resistances measured in specification and were typical.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated against the specified curve template/fixture and both the right and left curve failed to reach the specified template area.X-rays confirmed that the center support is broken and an end is poking up through the catheter shaft tubing.The distal section was dissected and body fluids were noted in the interior of the sheath.The kevlar wrap is slightly displaced; it does not cover the small curves¿ steering wire solder joint on the center support.The steering wires are attached to the center support.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause has been determined to be related to a supplier manufacturing issue.(b)(4).

Event Description

Reportable based on device analysis completed on 15-aug-2017.It was reported that a catheter distal end kink occurred.A blazer prime¿ xp was selected for use.During the procedure, a number of ablation burns were already performed when it was noticed under fluoroscopy that the catheter shape appeared to be kinked.Subsequently, the catheter was withdrawn from the patient¿s body and it was confirmed that the distal end of the catheter became kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However device analysis revealed that the end edge of the center support is poking out of the tubing at the bend.

• Brand Name: BLAZER PRIME¿ XP
• 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: 6844644
• MDR Text Key: 84978746
• Report Number: 2134265-2017-08677
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2020
• Device Model Number: M004EPTP4500THN40
• Device Catalogue Number: EPTP4500THN4
• Device Lot Number: 20117001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• 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