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

Model Number	87070
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter fracture occurred.A viking electrode catheter was selected for a electrophysiology procedure.However before the catheter was used it was noticed that the catheter was fractured.No patient complications were reported.
Additional Manufacturer Narrative
Visual inspection revealed that the shaft is bent and kinked at approximately 1.6cm, 7.3cm and 8.0cm from the tip.No tool marks are present.An electrical test was performed on all electrodes with multimeter and no electrical issues were found with this device.The reported failure was confirmed.
Event or Problem Description
It was reported that catheter fracture occurred.A viking electrode catheter was selected for a electrophysiology procedure.However before the catheter was used it was noticed that the catheter was fractured.No patient complications were reported.

• Brand Name: VIKING
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8433588
• Report Number: 2134265-2019-02694
• Device Sequence Number: 2015397
• Product Code: DRF
• UDI-Device Identifier: 08714729878476
• UDI-Public: 08714729878476
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K971265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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: 10/01/2020
• Device Model Number: 87070
• Device Catalogue Number: 87070
• Device Lot Number: 22736801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/14/2019
• Patient Sequence Number: 1