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

Model Number	M0044000350
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
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 long black hair was noted between the layers of the inner plastic packaging.A viking electrode catheter was selected for use.During preparation, the inner package was unpacked on the sterile field of the laboratory table.When the white peel-back seal was opened, a long black hair was noted between the layers of the inner plastic packaging.The device was replaced, and the procedure was completed.There were no patient complications reported as a result of this event.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this viking electrode catheter was visually inspected, and no defects were found.The reported event of 'packaging foreign matter' could not be confirmed due to a lack of evidence.
Event or Problem Description
It was reported that long black hair was noted between the layers of the inner plastic packaging.A viking electrode catheter was selected for use.During preparation, the inner package was unpacked on the sterile field of the laboratory table.When the white peel-back seal was opened, a long black hair was noted between the layers of the inner plastic packaging.The device was replaced, and the procedure was completed.There were no patient complications reported as a result of this event.The device is expected to be returned for analysis.

• 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22142134
• Report Number: 2124215-2025-36677
• Device Sequence Number: 15512080
• Product Code: DRF
• UDI-Device Identifier: 08714729878353
• UDI-Public: (01)08714729878353(17)260808(10)34596434
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/19/2025

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: 08/08/2026
• Device Model Number: M0044000350
• Device Catalogue Number: M0044000350
• Device Lot Number: 0034596434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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