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

Model Number 85020

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis to boston scientific.Per visual inspection the device presents a bent/kink in the proximal part of the tip.Also, there is a cut in the distal part of the catheter shaft.Functional test showed that 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.There is an open in the tip and second ring after continuity test finding.Per dissection test the cut in the catheter shaft was confirmed affecting the tip and the ring 2.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 24feb2022.It was reported that during a cardiac radiofrequency ablation procedure, a blazer ii catheter had poor contact and could not discharge.There were no issues regarding temperature.The catheter was discharged intermittently and could not be used normally.No error messages.Temperature control mode was in use.Procedure was completed with another of same device.No patient injury reported.Device was returned to boston scientific for analysis.However, device analysis revealed that there is a cut in the distal part of the catheter shaft.

• Brand Name: BLAZER II
• 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: 13805346
• MDR Text Key: 287613869
• Report Number: 2134265-2022-03075
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 08714729199939
• UDI-Public: 08714729199939
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P920047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2024
• Device Model Number: 85020
• Device Catalogue Number: 85020
• Device Lot Number: 0026795644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 70 KG