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

Model Number	87071
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection showed that the curve appeared to be curving in the opposite direction expected.The electrode 5 ring had moved distally on the shaft exposing the e5 signal wire and the silver epoxy.The signal wire was not connected to the electrode and the indent in the shaft insulation from where the electrode ring was originally located was visible.There were no tool marks on the electrode ring.Tip motion was evaluated against the curve template; the curve was reversed from what was expected.X-rays did not reveal any obvious anomalies.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
Reportable based on device analysis completed on 12jul2019.It was reported that the catheter curve was bad.During an ablation procedure with a viking electrode catheter, the catheter curvature was reversed making the device unusable.No patient complications occurred.Device analysis revealed that electrode 5 had been moved in the distal direction exposing the silver epoxy and electrode 5 signal wire.

• 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: 8866387
• Report Number: 2134265-2019-09330
• Device Sequence Number: 2078894
• Product Code: DRF
• UDI-Device Identifier: 08714729878162
• UDI-Public: 08714729878162
• Combination Product (Y/N): N
• Initial Reporter Country: AF
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

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: 10/17/2020
• Device Model Number: 87071
• Device Catalogue Number: 87071
• Device Lot Number: 0022813072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1