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 Entrapment of Device (1212); Material Frayed (1262); Material Deformation (2976)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 12/27/2021

Event Type  Injury  

Event Description

During a left atrial flutter procedure, the mapping catheter became stuck in the groin area and required an increase in the size of the incision at the access site and additional devices in order to remove the catheter.Initially when attempting to remove the mapping catheter from the patient, it could not be removed near the groin.The mapping catheter was cut and an attempt was made to try and upsize the original introducer.The original introducer was then able to be removed and after upsizing with three introducers and dilators, the mapping catheter dislodged.The mapping catheter was removed and spline b on the paddle was noted to be elongated in addition to being torn.A second mapping catheter was used and the procedure was able to be completed with no adverse consequences to the patient outside of having to create a larger access site.

Manufacturer Narrative

One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The electrodes were displaced and the pellethane tubing and splines were corrugated and torn.The paddle was returned cut from the catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the removal difficulty, entanglement, torn pellethane tubing, cut shaft and displaced electrodes 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: 13205253
• MDR Text Key: 283491291
• Report Number: 3005334138-2022-00002
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 8093480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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 Outcome(s): Required Intervention