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 Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/29/2023

Event Type  Injury  

Event Description

Related manufacturing ref: 3008452825-2023-00579 during a right ventricular outflow tract, premature ventricular contraction (rvot pvc) ablation procedure, the catheters became entangled with each other.Once the coronary sinus was cannulated, the hd grid catheter was being manipulated for insertion into the rvot, and the physician experienced difficulties advancing the catheter past the tricuspid valve.It would not go past the valve at all and kept prolapsing as visualized on ice.When attempting to remove the hd grid catheter for inspection, it seemed the hd grid and the inquiry catheter became entangled and became stuck together inside the short introducer.Since they were stuck in the short sheath, and would not release from the sheath, the catheters had to be cut outside of the groin and then the whole system was pulled out all together (the 9f sheath with the hd grid and cs catheter).Ice was used to check if the patient's heart was clear, the patient was sent for a ct scan to ensure nothing was left behind.The patient experienced some chest and back pain during manipulation when trying to remove the catheters.The case was then abandoned, and the patient left the room in stable condition.

Manufacturer Narrative

One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The distal portion of the paddle assembly was fractured and detached exposing the internal components.The fractured portion of the device was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported device entanglement and withdrawal difficulty is consistent with damage during 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: 18354489
• MDR Text Key: 330871095
• Report Number: 3005334138-2023-00577
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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 Lot Number: 9232160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• 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
• Treatment: INQUIRY¿ STEERABLE CATHETER
• Patient Outcome(s): Other