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	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure to treat atrial flutter a viking electrode catheter was selected for use.It was reported that "there was error in the machine" and the procedure was not completed.No patient complications were reported.
Additional Manufacturer Narrative
The device was received by boston scientific for analysis.Visual inspection did not reveal any external abnormalities.No kinks were visible on the catheter.The catheter curve was within specification and inside the out of plane dimension.No open circuits were observed during the continuity test.The reported observation in the field was not confirmed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
During an ablation procedure to treat atrial flutter a viking electrode catheter was selected for use.It was reported that "there was error in the machine" and the procedure was not completed.No patient complications were reported.

• 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: 12598577
• Report Number: 2134265-2021-12621
• Device Sequence Number: 3373610
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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: 04/21/2023
• Device Model Number: 87073
• Device Catalogue Number: 87073
• Device Lot Number: 0027178587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 68 KG