MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER PRIME HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	M004P5031THN40
Medical Device Problem Codes	Material Deformation (2976); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of returned product revealed a kink at the distal section caused by a bent center support observed under x-ray and confirmed after dissection; consequently, confirming the reported complaint, this condition of the center support could also have caused the ingress of fluids within the distal end; additionally, the device passes functional and electrical testing.Visual inspection failed due to the kink at the distal section and the broken adhesive.
Event or Problem Description
Reportable upon analysis completed on 25feb2019.It was reported that there was a temperature sencing issue and a catheter kink occurred.A blazer prime catheter was selected for a ablation procedure.Upon opening the package it was noted that the distal tip was bent.It was noticed that immediately upon initiating radiofrequency ablation the generator reached max temp of 50c.The power never got above 5w.The maestro 4000 generator was tested after the procedure and normal function was confirmed.No patient complications were reported.Analysis of the device revealed fluid ingress and broken adhesive.

• Brand Name: BLAZER PRIME HTD
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8390831
• Report Number: 2134265-2019-02043
• Device Sequence Number: 16590408
• Product Code: LPB
• UDI-Device Identifier: 08714729803607
• UDI-Public: 08714729803607
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P920047
• 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
• Report Date (Section B): 03/05/2019

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: 07/01/2021
• Device Model Number: M004P5031THN40
• Device Catalogue Number: 87122
• Device Lot Number: 22327640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 03/05/2019
• Patient Sequence Number: 1