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

Model Number	M0045031THK20
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the returned device revealed that the ring1 and ring 2 are flattened.The seals to both ring 1 and ring 2 are compromised.There is damage to the insulation between the tip and ring 1.Scrape marks extend from a cut in the seal between the tip and the shaft down to ring 3.A dark material is present on the scrape mark which has been ground into the insulation and ring 2 seal.There is a sticky substance area on the proximal shaft between approximately 39cm and 41.5cm from the distal tip.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.The measurements were repeated in the right and left curve configurations, and again, all measurements were within specifications and typical.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 (25064780), and the device was found within specifications.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 based on device analysis completed on 25-sep-2017.It was reported that signal interference and image issues occurred.The target lesion was located near the tricuspid valve.A blazer® ii htd was selected for use.During the procedure, as the catheter was connected, signal interference was noted.Also, the image was not shown on the screen.The device was removed from the swartz sheath.The procedure was completed with another of the same device.No patient complications reported and patient's status was stable.However, device analysis revealed that a foreign matter was noted on the device.Also, the seals to both ring 1 and 2 electrodes were compromised.It was further reported that the foreign matter was not observed during or after the procedure.

• 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: 6936099
• Report Number: 2134265-2017-09965
• Device Sequence Number: 13813937
• Product Code: LPB
• UDI-Device Identifier: 08714729172055
• UDI-Public: 08714729172055
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

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: 09/02/2018
• Device Model Number: M0045031THK20
• Device Catalogue Number: 5031THK2
• Device Lot Number: 0018314426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR