MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D-AVHD-DF16

Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.A request for additional analysis was made for an advisor hd mapping catheter with a complaint mode related to electrodes 3-4 having no signal and noise.Visual inspection concluded that electrodes 3-4 had been displaced.Functional testing revealed an open circuit of electrodes 3-4 which were isolated to the weld joint of the electrode ring and the wire within the paddle.Device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of the fractured conductor wire and displaced and flared electrodes is consistent with damage during use.

Event Description

During the procedure, there was distortion on the a spline of the hd grid catheter on the mapping system.There was also noise on the a spline egm signals on the recording system.The cables for the grid catheter were verified to be pinned correctly.The cables were replaced to a new set of cables and pinned correctly again with no resolution.The hd grid catheter was replaced, and the procedure was completed with no adverse patient consequences.

• Brand Name: ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11169506
• MDR Text Key: 226793201
• Report Number: 3005334138-2021-00017
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 7619862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• 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