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

Model Number 87120

Device Problem Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection showed some sections of the adhesive located around the electrode rings was found detached.No more visual damages were found during this inspection.The steering knob and the tension control knob functioned properly on both lock and unlock positions.An abnormal resistance was felt when actuating the steering mechanism and an audible click was heard.The device was actuated in order to check the curves and it was observed that the curves were inverted; when the right curve was actuated it was placed in the left shaded area of the template.The same happened with the left curve, when it was actuated it was placed in the right shaded area of the template.The out of plane test was done and it was possible to observe that the curve tip was out of the shaded area.The device failed the dimensional test.The device under test was inspected using the x-ray machine, however, no abnormalities were encountered.The device was dissembled and no abnormalities of damages that could have caused or contributed with reported event were found.Inside the shaft, excessive quantity of dry blood was found.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

Reportable based on device analysis completed on 08dec2020.It was reported that during an ablation procedure, the curve of the blazer prime catheter was not adequate and at the end of the procedure one of the curves was noted to be broken.A crunchy sound was also noted when attempting to make a curve and a crack was heard after the catheter was removed from the patient.The procedure was completed successfully without patient complications by using a different curve on the original device.The device was returned to boston scientific for analysis.However, device analysis revealed the adhesive located around the electrode rings was found broken on some sections.

• Brand Name: BLAZER PRIME HTD
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11066218
• MDR Text Key: 223442995
• Report Number: 2134265-2020-18398
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P920047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2020

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
• Device Operator: Health Professional
• Device Model Number: 87120
• Device Catalogue Number: 87120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 82