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	03/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed and a sticky substance was noted on the distal tip, on the shaft between the distal tip and ring 1, and on ring 1.Electrical test was performed and the device was found within specifications.No opens or shorts were found.The steering knob and the tension control knob functioned properly on both lock and unlock positions.The residue on the tip of the catheter was analyzed and was verified that the residues did not originate in manufacturing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2017.It was reported there was no signal from the catheter distal tip side.A blazer¿i htd was selected for use.During procedure, it was noted that there was no signal from the distal tip side of the catheter.Furthermore, the cable was replaced but the issue persisted.The device was replaced with another of the same device and the procedure was completed.No patient complications were reported and the patient status was good.However, device analysis revealed a foreign sticky substance on the distal tip.

• 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: 6701021
• Report Number: 2134265-2017-06811
• Device Sequence Number: 1948256
• Product Code: LPB
• UDI-Device Identifier: 08714729172055
• UDI-Public: (01)08714729172055(17)20191124(10)20003499
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2017

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: 11/24/2019
• Device Model Number: M0045031THK20
• Device Catalogue Number: 5031THK2
• Device Lot Number: 20003499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR