MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER DX-20; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 86700

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/28/2022

Event Type  malfunction  

Event Description

During preparation of a right atrial flutter procedure, a blazer dx catheter was selected for use.Upon opening the package, something black was observed behind the steerable bi-wing knob.An exchange of the catheter resolved the issue to complete the procedure.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was visually inspected which revealed a black foreign material in the steering knob, confirming the reported clinical observation.

Event Description

During preparation of a right atrial flutter procedure a blazer dx catheter was selected for use.Upon opening the package something black was observed behind the steerable bi-wing knob.An exchange of the catheter resolved the issue to complete the procedure.

• Brand Name: BLAZER DX-20
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 15809413
• MDR Text Key: 306891098
• Report Number: 2124215-2022-47359
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729780526
• UDI-Public: 08714729780526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0029317698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1