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

Model Number	M0045031T0
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned for analysis.A visual inspection was performed.There was a bend located approximately 6cm from the distal tip.The torque hole is filled with dried body fluid.No adhesive in the hole is visible.There is dried body fluid on the handle.Electrical test was performed.Continuity checks revealed no electrical opens or shorts, as checked manually using a multi-meter and test cable.All electrode/thermistor resistances measured in spec and were typical.The thermistor resistance measurements were repeated in the right and left curve positions and the measurement remained steady and within specifications.Functional inspection was performed.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 ablation was verified by using the maestro generator 4000 and the device was found within specifications.Dissection of the device was performed.The insulation was removed both distal and proximal to the torque hole.There is no evidence of adhesive in the interior.There is dried blood throughout the shaft.The handle was opened; there is no evidence of body fluid inside the handle.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 22nov2017 it was reported that high temperature readings occurred.A blazer® ii was selected for use.During the procedure, it was noted that high temperature readings was encountered when connected with the maestro 3000.No patient complications were reported.However, device analysis revealed a hole on the device.

• Brand Name: BLAZER® II
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7070532
• Report Number: 2134265-2017-12070
• Device Sequence Number: 945078
• Product Code: LPB
• UDI-Device Identifier: 08714729082811
• UDI-Public: 08714729082811
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 02/23/2020
• Device Model Number: M0045031T0
• Device Catalogue Number: 5031T
• Device Lot Number: 20326329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1