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 Problem Communication or Transmission Problem (2896)

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

Event Date 01/28/2022

Event Type  malfunction  

Event Description

Related manufacturer ref #2184149-2022-00042; 3005334138-2022-00178; 3005334138-2022-00177; 3005334138-2022-00180; 3008452825-2022-00054; 3008452825-2022-00055; 3008452825-2022-00056; 3008452825-2022-00057; 3008452825-2022-00073; 3008452825-2022-00074.During the atrial fibrillation ablation procedure, error messages were noted which caused a delay.Catheter connection to the ensite x system was confirmed.The prs was successfully connected, but the following error message was displayed: "surface electrode impedance error.Confirm original surface electrode placement.Revalidation is recommended if the patch has moved to a new location.".Revalidation was attempted several times, but the error persisted.The module patch on the right foot was replaced and revalidated.As this did not resolve the issue, the original patch was utilized.The surfacelink was replaced and the amplifier was power cycled, but the issue persisted.The tacticath and advisor hd grid catheters were exchanged.After the catheters were exchanged, the following error messages were displayed: "the catheter was used by another patient."."end study" was selected and the amplifier was restarted, but the error message persisted.The tacticath and advisor hd grid catheters were both replaced again.The ensite dws and amplifier were restarted."end study" was selected again and existing patient was selected, at which point the catheter was displayed.The tip of the electrode of the tacticath was lit in red, and the potential of the tacticath was displayed for about 20 seconds.The body surface ecg was not displayed and the following error message appeared: "amplifier time synchronization failed.Contact abbott technical service if problem persists.".The amplifier was exchanged and the ensite dws was restarted.The tacticath and advisor hd grid catheters were replaced for a third time.The surface electrode was replaced for a second time, but the issue persisted.The surfacelink was replaced again, but the body surface ecg and potential were still not displayed.The prs connection was unstable.At this point, the catheter was displayed and the amplifier connection remained stable.Troubleshooting was unable to resolve the issue.A non-abbott system was used to complete the procedure with no adverse consequences to the patient.

Manufacturer Narrative

Additional information d9, g3, h2, h3, h6 one bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.Electrodes 1-18 met specifications for acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported error message and subsequent delay remains unknown.

• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13653233
• MDR Text Key: 286997810
• Report Number: 3005334138-2022-00179
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 8167889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 68 KG