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

Model Number M0044500THK20

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn and lot provided by the customer.The device has a kink at the distal section while in the neutral position at 5 cm from the tip.In addition the device has a char in the tip.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 22dec2016.It was reported that the device was unable to ablate.A 7 / 110 / 2.5 / 8-8 qd k2 htd blazer ii xp was selected to treat the lesion.During the procedure, it was noted that the device was unable to ablate.The temperature was reading at 130 and was unable to deliver power.Physician reset system and changed cables but it did not change.The device was then removed and the procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that a char on the distal tip was noted.

• Brand Name: BLAZER® II 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: 6260142
• MDR Text Key: 65079726
• Report Number: 2134265-2016-12562
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729452287
• UDI-Public: (01)08714729452287(17)20190901(10)0019641545.
• 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
• Type of Report: Initial
• Report Date: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Model Number: M0044500THK20
• Device Catalogue Number: 4500THK2
• Device Lot Number: 0019641545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• 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