MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number D-AVHD-DF16

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

During an atrial flutter procedure, a white clear thread like material was wrapped around the paddle at the kinked spline when the mapping was completed, and the catheter was removed from the patient.It was noted that one of the catheter splines was kinked.The catheter was not reintroduced into the patient.The procedure was completed and there were no adverse consequences to the patient.

Manufacturer Narrative

Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in d3.The correct mfr number is 3005334138.

Manufacturer Narrative

One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The catheter had a foreign material wrapped around the distal coupler cap.The s&t report identified the foreign material as ptfe (poly tetraflouroethylene).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the foreign material remains unknown.

• Brand Name: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; edificio #44b, calle 0, avenida 2, coyol; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; edificio #44b, calle 0, avenida 2, coyol; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17557012
• MDR Text Key: 321350915
• Report Number: 3008452825-2023-00353
• 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,Followup
• Report Date: 11/03/2023

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: 9041540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 10/25/2023; 11/02/2023
• Supplement Dates FDA Received: 10/25/2023; 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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