MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER® II HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	M0045031TH0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer: the device was returned for analysis.A visual inspection of the device revealed that there is dried body fluid on the handle, shaft, in the torque hole and on the distal tip.The seal on the torque hole appears to have been compromised.There is a bend in the distal end located approximately 5cm from the distal tip in the neutral position.Electrical test continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and test cable.All electrode/thermistor/sensor resistances measured in spec and were typical.Functional inspection revealed that 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.¿ during dimensional inspection, the tip motion was evaluated against the specified curve template/fixture.Results revealed that the right and left curve are inversed, that is, when the steering knob is moved clockwise, the curve deflects to the left when it should curve right and vice versa.The tip reaches the specified template area for both curves.The torque hole is on the underside of the shaft for both curves which indicates that the proximal shaft is not twisted.X-rays showed a bent center support.No abnormalities were seen in the handle.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 10-jul-2017.It was reported that device steering mechanism was broken.A7/110/2.5/7-4 quad blazer® ii htd was selected for use.During unpacking, it was noted that the device had a broken deflection mechanism.No patient complications were reported.However, device analysis revealed that the seal on the torque hole appears to have been compromised.

• Brand Name: BLAZER® II HTD
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6751009
• Report Number: 2134265-2017-07416
• Device Sequence Number: 13726996
• Product Code: LPB
• UDI-Device Identifier: 08714729172048
• UDI-Public: (01)08714729172048(17)20191110(10)19937672
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2017

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: 11/10/2019
• Device Model Number: M0045031TH0
• Device Catalogue Number: 5031TH
• Device Lot Number: 19937672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1