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

Model Number	85270
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the curve would not straighten.During a right atrial flutter procedure involving a blazer ii xp catheter while inside the body, the catheter retained the curve and it would not straighten out and stayed curved.The catheter was exchanged and the procedure was completed with no complications to the patient and was fine.
Additional Manufacturer Narrative
Visual inspection showed the device has a kink at the distal section approximately at 9.5 cm from the distal tip while in the neutral position.Functional inspection showed the steering knob and the tension control knob functioned properly on both lock and unlock positions.There are no abnormal resistance was felt when actuating the steering mechanism.Dimensional test showed the right curve was placed in the specified shaded area of the template; however, the left curve failed to reach the specified area, the device failed the dimensional test.X-ray inspection showed the bent center support was observed under x-ray in the same location of the kink at the distal section.Distal end was dissected and was confirmed bent center support 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 curve would not straighten.During a right atrial flutter procedure involving a blazer ii xp catheter while inside the body, the catheter retained the curve and it would not straighten out and stayed curved.The catheter was exchanged and the procedure was completed with no complications to the patient and was fine.

• Brand Name: BLAZER II 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: 8735229
• Report Number: 2134265-2019-07466
• Device Sequence Number: 1977719
• Product Code: OAD
• UDI-Device Identifier: 08714729452287
• UDI-Public: 08714729452287
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: 02/12/2022
• Device Model Number: 85270
• Device Catalogue Number: 85270
• Device Lot Number: 0023344324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1