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

Model Number	87141
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device does not have visual defects.Rings were inspected and ring #2 seal was found compromised, broken adhesive was observed; there is dried body fluid on the edge of the electrode.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 right curve was placed in the specified shaded area of the template.The left curve failed to reach the specified area since there was no movement of the tip during steering knob actuation.The left steering wire was separated from the center support and has retracted back between ring #2 and ring #3.The catheter was dissected and it was noted that the kevlar wrap was found retracted.The distal tip was dissected and was confirmed the left steering wire separated from the center support due to a broken solder joint; however, remnants of solder were found on the center support where the left steering wire used to be attached.The kevlar wrap was exposed in order to measure it and was found out of specification.
Event or Problem Description
Reportable based on device analysis completed on 03jun2019.It was reported that the catheter was defective.During a procedure with a blazer prime xp "it was a bad catheter, it wouldn't work".They finish the case with another catheter of the same size.No patient complications occured.However, returned device analysis revealed broken adhesive on ring #2.

• 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: 8674993
• Report Number: 2134265-2019-06478
• Device Sequence Number: 14189942
• 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): 06/06/2019

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: 01/28/2022
• Device Model Number: 87141
• Device Catalogue Number: 87141
• Device Lot Number: 0023265730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/06/2019
• Patient Sequence Number: 1
• Patient Age: 81 YR