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

Model Number	D-AVSE-DF10-F20
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the catheter became stuck in the sheath.When attempting to insert the mapping catheter into the sheath without using the insertion aid, the tip became stuck in the sheath.The insertion aid was advanced afterwards and the tip of the catheter would not move forward or backward.The physician then pulled the insertion aid and catheter tip out of the sheath and the tip of the catheter tore off.The sheath was pulled out of the patient to ensure that no fragment of the catheters remained in the patient.The catheter and the sheath were replaced to complete the procedure with no consequences to the patient.
Additional Manufacturer Narrative
One 20mm loop, bi-directional, curve d-f, sensor enabled, advisor fl circular mapping catheter was received for evaluation.Electrode ring 4 was noted to be flared.The catheter shaft and distal tip electrode were fractured and detached from the loop.The catheter was unable to be inserted into an introducer due to the aforementioned damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the physical damage, flared electrode and reported insertion difficulty remains unknown.
Additional Manufacturer Narrative
Correction: h6.One 20mm loop, bi-directional, curve d-f, sensor enabled, advisor fl circular mapping catheter was received for evaluation.The 8.5f fast-cath introducer used in conjunction with this catheter was also returned.The reported event of catheter stuck inside sheath was confirmed.The returned catheter distal tip had been fractured and was returned stuck inside the sheath sideport.The catheter was unable to be inserted into an introducer due to the aforementioned damage.Artmt600057193 ver.A, advisor fl circular mapping catheter instructions for use (ifu), ¿directions¿ section states, ¿slide the loop straightener over the distal loop section of catheter.¿ then ¿insert loop straightener with the catheter distal end into and through the hemostasis valve of the introducer.¿ then ¿insert catheter through the hemostasis valve.¿ the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the catheter stuck inside sheath and the flared electrode is consistent with not following the instructions for use.

• Brand Name: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16513137
• Report Number: 3008452825-2023-00089
• Device Sequence Number: 6239764
• Product Code: DRF
• UDI-Device Identifier: 05415067025968
• UDI-Public: 05415067025968
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: D-AVSE-DF10-F20
• Device Catalogue Number: D-AVSE-DF10-F20
• Device Lot Number: 8725631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 03/06/2023; 06/06/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/25/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown