MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER PRIME XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004P4500THK20
Medical Device Problem Codes	Mechanics Altered (2984); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on 14-dec-2018.It was reported that loss of steering occurred.A blazer prime xp was selected for a procedure however the tip and the steering aspect of the device was defective, they could not get it to work.The procedure was completed with another blazer prime xp.No patient complications occurred.However, returned device analysis revealed fluid ingress and broken adhesive on ring 1.Analysis of returned product revealed a kink at the distal section caused by a bent center support confirmed after dissection; consequently, confirming the reported complaint, this condition of the center support could also have caused the ingress of fluids within the distal end.Visual inspection failed due to the kink at the distal section and the broken adhesive in ring 1.Dimensional inspection failed due to the curve failed to reach the specified area of the template and the short kevlar.

• Brand Name: BLAZER PRIME XP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8235448
• Report Number: 2134265-2018-64997
• Device Sequence Number: 950050
• Product Code: OAD
• UDI-Device Identifier: 08714729802334
• UDI-Public: 08714729802334
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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: 10/03/2021
• Device Model Number: M004P4500THK20
• Device Catalogue Number: 87141
• Device Lot Number: 0022751062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1