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

Model Number 87070

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/22/2020

Event Type  malfunction  

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 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 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.

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
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10361683
• MDR Text Key: 201535031
• Report Number: 2134265-2020-10438
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729878100
• UDI-Public: 08714729878100
• Combination Product (y/n): N
• PMA/PMN Number: K971265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 10/06/2020
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 49