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); Fracture (1260); Material Frayed (1262); Material Twisted/Bent (2981)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

Related manufacturer ref: 3005334138-2021-00711.During an atrial fibrillation, when attempting to remove the mapping catheter from the introducer, it became stuck.It was then attempted to remove both the mapping catheter and introducer at the same time, but the two could not be removed.The incision was enlarged at the vascular site and the catheter and introducer were then able to be removed.Upon removal, both the catheter and introducer were noted to be torn and bent at the tips.The procedure was continued as the mapping portion was completed.

Manufacturer Narrative

Additional information: b5, d9, g3, h2, h3, h6.One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The straightener was not returned.The electrodes were displaced and the pellethane tubing and splines were corrugated and torn.The catheter was unable to be inserted into a stock introducer since the straightener was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the withdrawal difficulty, torn pellethane tubing, and displaced electrodes remains unknown.

Event Description

This report is to advise of an event observed during analysis confirming torn shaft material of the catheter.

• 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: 12866732
• MDR Text Key: 282102533
• Report Number: 3005334138-2021-00712
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 8049702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• 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