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

Model Number	87152
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event 18 years or older.Device was evaluated by boston scientific.Analysis of returned product revealed a kink at the distal section caused by a bent and broken center support observed under x-ray.This was confirmed after dissection, the canter support was also fond to be protruding the shaft.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.
Event or Problem Description
It was reported that a blazer prime xp was used in an ablation procedure, it was noted during the procedure that the physician did not feel the tip of the catheter came into contact with tissue during energization.The catheter was removed and was noted to have the distal end twisted with a wire perforating the insolation proximal the first ring electrode.The catheter was replaced and the procedure was completed without patient complications.

• Brand Name: BLAZER PRIME XP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10390628
• Report Number: 2134265-2020-10915
• Device Sequence Number: 2942268
• Product Code: OAD
• UDI-Device Identifier: 08714729802372
• UDI-Public: 08714729802372
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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: 06/21/2021
• Device Model Number: 87152
• Device Catalogue Number: 87152
• Device Lot Number: 0022289432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1