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

Model Number	86700
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the device showed damage on the shaft near to the ring # 20.It looks like it was burnt with a external object because no damages were found on the signal wires.Electrical continuity test was performed, no open circuit and no short circuits were found.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.
Event or Problem Description
Reportable based on analysis completed on 03 mar 2021.It was reported that during preparation of a blazer dx-20 the electrode did not work.The procedure was completed by exchanging the catheter.However analysis revealed catheter shaft damage.

• Brand Name: BLAZER DX-20
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11542750
• Report Number: 2134265-2021-03672
• Device Sequence Number: 14586856
• Product Code: DRF
• UDI-Device Identifier: 08714729780533
• UDI-Public: 08714729780533
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: 09/17/2023
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0026033551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/22/2021
• Patient Sequence Number: 1
• Patient Age: 74 YR