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

Model Number 87073

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

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 during preparation for a procedure a viking 6f electrode catheter was selected for use.Upon unpacking, the physician found that the device shaft was fractured.The catheter was replaced and the procedure was completed successfully.No patient complications were reported.The device is expected to be returned for laboratory analysis.

Manufacturer Narrative

Viking 6f catheter was evaluated by boston scientific.Visual inspection of the device noticed that the connector was detached from the catheter shaft, it is important to mention that adhesive was observe on the catheter at the detached section.The reported allegation was confirmed by the laboratory analysis.This investigation is assigned a conclusion code of "adverse event related to procedure" which indicates that the adverse event occurred during the procedure and the device had no influence on the event.

Event Description

It was reported that during preparation for a procedure a viking 6f electrode catheter was selected for use.Upon unpacking, it was found that the device was fractured.The device was replaced and the procedure was completed successfully.No patient complications were reported.The device has been received at a boston scientific post market laboratory.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17625864
• MDR Text Key: 321980723
• Report Number: 2124215-2023-45250
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729878872
• UDI-Public: 08714729878872
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

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 Model Number: 87073
• Device Catalogue Number: 87073
• Device Lot Number: 0030145233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1