MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIKING; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	87073
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during preparation for a procedure a viking 6f electrode catheter was selected for use.Upon unpacking, the physician found that the device shaft was fractured.The catheter was replaced and the procedure was completed successfully.No patient complications were reported.The device is expected to be returned for laboratory analysis.
Additional Manufacturer Narrative
Viking 6f catheter was evaluated by boston scientific.Visual inspection of the device noticed that the connector was detached from the catheter shaft, it is important to mention that adhesive was observe on the catheter at the detached section.The reported allegation was confirmed by the laboratory analysis.This investigation is assigned a conclusion code of "adverse event related to procedure" which indicates that the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that during preparation for a procedure a viking 6f electrode catheter was selected for use.Upon unpacking, it was found that the device was fractured.The device was replaced and the procedure was completed successfully.No patient complications were reported.The device has been received at a boston scientific post market laboratory.

• Brand Name: VIKING
• Common Device Name: 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: 17625864
• Report Number: 2124215-2023-45250
• Device Sequence Number: 12588236
• Product Code: DRF
• UDI-Device Identifier: 08714729878872
• UDI-Public: 08714729878872
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: 09/13/2024
• Device Model Number: 87073
• Device Catalogue Number: 87073
• Device Lot Number: 0030145233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown