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

Model Number	87073
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
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 the label on the outer package was different than the label on the inner package.During an arrhythmia procedure in the heart a viking electrode catheter was selected for use.The model of the device was different from the outer package and inner package.The outer package was labeled fixed curve diagnostic catheter 10e, but the inner package was labeled diagnostic catheter 4e.The catheter was replaced and the procedure was completed without patient complications.
Event or Problem Description
It was reported that the label on the outer package was different than the label on the inner package.During an arrhythmia procedure in the heart a viking electrode catheter was selected for use.The model of the device was different from the outer package and inner package.The outer package was labeled fixed curve diagnostic catheter 10e, but the inner package was labeled diagnostic catheter 4e.The catheter was replaced and the procedure was completed without patient complications.
Additional Manufacturer Narrative
The device has been evaluated by boston scientific and visual inspection revealed the complaint device returned with its original outer box labeled as decapolar; however, returned unit is a quadpolar.Additionally, there was no match between the upn in outer box (m0044001000) and the one printed on the connector of the catheter (m0044000100).The media inspection revealed the customer attached pictures showing the mismatch between outer box, pouch and viking device electrode configuration.

• 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
• MDR Report Key: 10343634
• Report Number: 2134265-2020-10200
• Device Sequence Number: 811562
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 02/13/2021
• Device Model Number: 87073
• Device Catalogue Number: 87073
• Device Lot Number: 0023344875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/29/2020
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 65