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 Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.A visual examination revealed that the device was returned in a right curve position.There is a dried blood on the tip.The seal is compromised on ring 2 and ring 3.There are striations on the insulation that suggest that the distal end has been twisted in a clockwise manner.There are parallel marks around the circumference of the insulation located approximately 2.6cm from the distal end.The marks start from the proximal end of ring 3 and extend approximately 0.5cm toward the handle.Continuity checks revealed no electrical shorts as checked manually using a multi-meter and test cable.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 device passes through an 8fr gauge without difficulty.This device has an 8fr tip.X-ray indicated a broken wire on the proximal side of electrode ring 1, ring 2 and ring 3.It appears the wires are twisted in the distal end around the steering mechanism from the transition area to ring 3.The distal end was dissected.All three electrode wires were confirmed to be disconnected from the electrodes.A segment of the wire is still attached to each of the electrodes.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 23-jan-2018.It was reported that no signal occurred.A blazer® ii xp was selected for use.During procedure, when the blazer® was inserted into the body and the cable was connected, it was noted that there was no electrical signals.The physician attempted to replace the cable; however, issue was not resolved.Finally, the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, device analysis revealed that the seals on ring 2 and ring 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: 7248263
• Report Number: 2134265-2018-00821
• Device Sequence Number: 16393184
• Product Code: OAD
• UDI-Device Identifier: 08714729452287
• UDI-Public: 08714729452287
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/23/2018

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: 11/07/2019
• Device Model Number: M0044500THK20
• Device Catalogue Number: 4500THK2
• Device Lot Number: 19924622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1