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	Mechanics Altered (2984); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has a kink at the distal section approximately at 1.2 cm from the distal tip while in the neutral position.Another kink was observed at 76 cm from the distal tip while in the neutral position.Rings were inspected and ring #1, ring #2 and ring #3 seals were found compromised, broken adhesive was observed; there is dried body fluid on the edge of the electrode and the shaft was found broken where the center support was found bent.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; however the left curve failed to reach the specified area, the device failed the dimensional test.Bent center support was observed under x-ray 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.Distal end was dissected and was confirmed bent center support 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.The kevlar wrap was found retracted.Dried body fluid was found within the distal end.The kevlar wrap was exposed in order to measure it, the kevlar wrap was found out of specification.
Event or Problem Description
Reportable upon analysis completed on 04jun2019.It was reported that poor curve and deflection issues occurred.A blazer prime was selected for a procedure, however it was noticed during the procedure that the catheter had an irregular curve shape and then the catheter wouldn't curve correctly.The procedure was completed using another of the same with no patient complications occurring.However, returned device analysis revealed broken ring adhesive and fluid ingress.

• 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: 8752374
• Report Number: 2134265-2019-07710
• Device Sequence Number: 13934650
• Product Code: OAD
• UDI-Device Identifier: 08714729802334
• UDI-Public: 08714729802334
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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: 05/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/02/2019
• Patient Sequence Number: 1