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

Model Number	87070
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	07/22/2020
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.A viking catheter was selected for use.The model on the outer package was fixed curve catheter 4e, but the model on the inner aseptic package was fixed curve catheter 10e and the device was a fixed curve catheter 10e an exchange of the catheter resolved the issue.There were no patient complications reported.
Event or Problem Description
It was reported that the label on the outer package was different than the label on the inner package.A viking catheter was selected for use.The model on the outer package was fixed curve catheter 4e, but the model on the inner aseptic package was fixed curve catheter 10e and the device was a fixed curve catheter 10e an exchange of the catheter resolved the issue.There were no patient complications reported.
Additional Manufacturer Narrative
The device was sent to boston scientific for analysis.Visual inspection revealed a mismatch between original outer box (quadpolar) and the returned unit and pouch (decapolar); consequently, confirming the reported complaint.The packaged unit (10-electrodes configuration) matched with what is labeled in the pouch.On the other hand, the box label did not match with the rest of components involved, therefore a deep investigation was conducted finding that not only the batch number of the labels is different but the manufacturing day, determining that as the time interval between both components (box label / pouch label) is considerably large (around seven (7) months of difference).Consequently, there is evidence enough to reject the suspected that the device manufactured on feb 21st, 2019 was packaged using a carton box labeled 7 months later, since it is not likely to happen in the manufacturing/boxing process therefore not confirming the allegation.

• 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: 10361683
• Report Number: 2134265-2020-10438
• Device Sequence Number: 2408819
• Product Code: DRF
• UDI-Device Identifier: 08714729878100
• UDI-Public: 08714729878100
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 09/15/2021
• Device Model Number: 87070
• Device Catalogue Number: 87070
• Device Lot Number: 0024437478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 10/06/2020
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 49