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

Model Number	M0044500THK20
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6260142
• Report Number: 2134265-2016-12562
• Device Sequence Number: 938579
• Product Code: OAD
• UDI-Device Identifier: 08714729452287
• UDI-Public: (01)08714729452287(17)20190901(10)0019641545.
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2016

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2016
• Initial Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1