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 Codes	Material Integrity Problem (2978); Mechanics Altered (2984)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age: 18 years or older.
Event or Problem Description
It was reported that the catheter tip was severely broken/damaged.During an ablation procedure, a blazer prime xp was being used for a myocardial ablation to treat atrial flutter (afl) in the right inguinal region.After cauterizing/ablating the isthmus an abnormality in the bending of the catheter was felt, and when it was taken out of the patient, the catheter tip was found to be damaged.The procedure was successfully completed, and there was no adverse effect to the patient.
Additional Manufacturer Narrative
Patient age: 18 years or older.The device was returned for analysis.The unit was returned in a generic plastic bag, and the overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device had a kink at the distal section approximately at 1.5 cm from the distal tip while in the neutral position.This condition could have caused the breakage of the shaft leading to a protrusion of the center support and steering wire through the shaft of the device.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 left curve was placed in the specified shaded area of the template.The right curve failed to reach the specified area since there was no movement of the tip during steering knob actuation.Bent and broken center support was observed under x-ray between ring 1 and ring 2 at the distal section; in addition, the steering wire was also broken in the same location.Distal end was dissected and was confirmed broken center support and broken steering wire in the same location of the kink at the distal section.A steering wire partially detached from the center support due to broken solder joint was also observed; in addition, this steering wire was found broken in the same location of the kink at the distal section.The kevlar wrap was found retracted.The kevlar wrap was exposed in order to measure it and the result was found out of specification.
Event or Problem Description
It was reported that the catheter tip was severely broken/damaged.During an ablation procedure, a blazer prime xp was being used for a myocardial ablation to treat atrial flutter (afl) in the right inguinal region.After cauterizing/ablating the isthmus an abnormality in the bending of the catheter was felt, and when it was taken out of the patient, the catheter tip was found to be damaged.The procedure was successfully completed, and there was no adverse effect to the patient.

• 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: 8697361
• Report Number: 2134265-2019-06902
• Device Sequence Number: 11264058
• Product Code: OAD
• UDI-Device Identifier: 08714729802334
• UDI-Public: 08714729802334
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020025
• 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,Followup
• Report Date (Section B): 07/24/2019

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: 01/16/2022
• Device Model Number: 87141
• Device Catalogue Number: 87141
• Device Lot Number: 0023204602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1