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 Fracture (1260); Difficult to Remove (1528)

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

Related manufacture ref: 3005334138-2023-00540.During an atypical atrial flutter ablation procedure, exposed wires were noted on the catheter.After completing the map in right atrium (ra), it was understood that the arrhythmia origin was in the left atrium (la).Transseptal puncture was then performed with swartz lamp introducer and brk-1 xs needle.After the puncture, the hd grid was placed in a long sheath to bring it in the la, however, difficulties were noted removing it from the short introducer (boston scientific, 8f).It was finally able to be removed but was damaged with exposed wires.

Manufacturer Narrative

Additional information: g3, h2, h3 one image was submitted for evaluation to product performance engineering; no device components were returned.The photo appeared to show an advisor hd grid paddle with damage.The paddle assembly appeared to be damaged, exposing the nitinol frame.Visual inspection was based solely upon a review of the photographs provided.The device was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Arten600124477 ver.B advisor hd grid diagnostic catheter instructions for use (ifu) states, ¿insert the distal tip section of catheter into an 8.5 f minimum introducer (not included) using the insertion tool¿.The cause of the paddle damage and removal difficulty is consistent with not following the instructions for use.

• 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: 18160045
• MDR Text Key: 328404829
• Report Number: 3005334138-2023-00539
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/01/2024

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: D-AVHD-DF16
• Device Lot Number: 9138486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER, LAMP.