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

Model Number	M0044000040
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been evaluated.Upon 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 the device was difficult to advance, move or steer, and withdraw.A kink was also observed.During an electrophysiology procedure to treat atrial fibrillation, a viking electrode catheter was used.Upon insertion, the catheter became difficult to advance, move or steer, and withdraw in the vein.The catheter was also bent and kinked.No resistance was felt while maneuvering the catheter.Another of the same device was used, and the procedure was completed without patient complications.The device has been received, pending analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this viking electrode catheter was visually inspected, and it was found that the shaft was kinked.Media inspection on the photo and video provided also observed a kink in the fluoroscopy.Product analysis confirmed the reported events of catheter difficult to withdraw, curve kinked, and catheter difficult to advance.The reported events were most likely due to the handling of the device, the technique used by the physician, and the normal difficulties encountered during the procedure which could have possibly affected the device performance and integrity.
Event or Problem Description
It was reported that the device was difficult to advance, move or steer, and withdraw.A kink was also observed.During an electrophysiology procedure to treat atrial fibrillation, a viking electrode catheter was used.Upon insertion, the catheter became difficult to advance, move or steer, and withdraw in the vein.The catheter was also bent and kinked.No resistance was felt while maneuvering the catheter.Another of the same device was used, and the procedure was completed without patient complications.The device has been received and analyzed.Additional information received on december 04, 2025.The catheter became twisted within the blood vessel and could no longer be advanced.After several attempts, it was eventually withdrawn.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on december 04, 2025.Block h6 has been corrected.The device has not yet been evaluated.Upon 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 the device was difficult to advance, move or steer, and withdraw.A kink was also observed.During an electrophysiology procedure to treat atrial fibrillation, a viking electrode catheter was used.Upon insertion, the catheter became difficult to advance, move or steer, and withdraw in the vein.The catheter was also bent and kinked.No resistance was felt while maneuvering the catheter.Another of the same device was used, and the procedure was completed without patient complications.The device has been received, pending analysis.Additional information received on december 04, 2025.The catheter became twisted within the blood vessel and could no longer be advanced.After several attempts, it was eventually withdrawn.

• 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: 23679768
• Report Number: 2124215-2025-86103
• Device Sequence Number: 21293627
• Product Code: DRF
• UDI-Device Identifier: 08714729878049
• UDI-Public: (01)08714729878049(17)270514(10)36518131
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 01/20/2026

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 Model Number: M0044000040
• Device Catalogue Number: M0044000040
• Device Lot Number: 0036518131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 12/26/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/25/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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