MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER® II XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M0044500TH0
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The device was received in the left curve position.There is a crease in the sheath approximately 64.6cm from the distal tip; it appears the shaft was pinched, all three ring seals are compromised; there is dried body fluid along the edges of all three rings.A tubing protector was received with the device.Electrical test and rf ablation test were performed and the device was found within specifications.No opens or shorts were found.There was no indication that analysis results were affected the decontamination process.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 08-feb-2017.It was reported that the poor temperature control occurred.A blazer® ii xp was selected for use.During procedure, the generator would give a "temp out of range" error as the temperature would only reach 46 degree celsius.The cable was replaced but the same results would occur.The generator was reset; however, still the same issue persisted.The catheter was removed from the patient's body.The procedure was completed with another unspecified blazer catheter.No patient complications were reported.However, device analysis revealed that all three ring seals are compromised as there were dried body fluid along the edges of the rings.

• 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: 6367919
• Report Number: 2134265-2017-01411
• Device Sequence Number: 16317135
• Product Code: OAD
• UDI-Device Identifier: 08714729452270
• UDI-Public: (01)08714729452270(17)20191103(10)19899882
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

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: 11/03/2019
• Device Model Number: M0044500TH0
• Device Catalogue Number: 4500TH
• Device Lot Number: 19899882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1