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

Model Number M004P4790THN40

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.  it was reported that the device unable to deliver current and catheter bent occurred.  the target lesion was located in the cavotricuspid isthmus lesion.A 7-110-2.5-8-10 blazer prime® xp was selected to treat the lesion.However, it was noted that the device was unable to deliver current.The physician checked the catheter under fluoroscopic control and noted that the was catheter bent. the procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was good.  however, returned device analysis revealed that the device has a broken adhesive at ring 3.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Visual inspection of the returned device revealed a kink at the distal section while in the neutral position at 2.2cm from the tip.The device has a broken adhesive at ring 3 and blood evidence under the adhesive of the ring 3.The ring damage is in the same location of the kink.The ablation was verified by using the maestro generator 3000 and the device was found within specification.Electrical test was performed, and the device was found within specification.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)(6).

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4037771
• MDR Text Key: 16854086
• Report Number: 2134265-2014-05131
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2017
• Device Model Number: M004P4790THN40
• Device Catalogue Number: P4790THN4
• Device Lot Number: 16624309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2014
• 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
• Treatment: GENERATOR: MAESTRO