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	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The device was returned in a left curve position.There are bends located approximately 2cm and 5cm from the distal tip.Ring 2 and ring 3 seals are compromised.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.The left curve reached past the specified template area.The right curve test passed.X-ray confirmed two bends in the center support.The start of guide coil collapse was also noted in the handle.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 12-jan-2018.It was reported that the catheter curve would not steer properly.A 7 / 110 / 2.5 / 8-8 blazer® ii xp was selected for use.During the procedure, it was noted that the catheter curve would not steer properly in one direction.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the seals of rings 2 and 3 were compromised.

• 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: 7219860
• Report Number: 2134265-2018-00443
• Device Sequence Number: 11066054
• Product Code: OAD
• UDI-Device Identifier: 08714729452287
• UDI-Public: 08714729452287
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/12/2018

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: 09/11/2020
• Device Model Number: M0044500THK20
• Device Catalogue Number: 4500THK2
• Device Lot Number: 0021123295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1