MAUDE Adverse Event Report: ABBOTT MEDICAL ADVISOR¿ VL, SENSOR ENABLED¿ CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D-AVSE-DF20-V1525
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, the loop of the catheter was damaged and got caught on heart tissue.When the catheter was inserted into the left atrium, it was found that the catheter maneuvering and collection of geometry were difficult.The catheter was removed with no intervention needed, and it was noted to be damaged.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 22 pole, bi-directional, curve d-f, sensor enabled, advisor vl circular mapping catheter was received for evaluation.Visual inspection revealed the loop was both bent and wrinkled.The catheter deflected in both directions when actuating the steering mechanism and the curve dimensions met specifications.Due to the damage to the loop, it did not meet specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported fracture and entrapment event remains unknown.

• Brand Name: ADVISOR¿ VL, SENSOR ENABLED¿ CIRCULAR MAPPING CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ABBOTT 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): ABBOTT 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22323573
• Report Number: 3008452825-2025-00306
• Device Sequence Number: 18346062
• Product Code: DRF
• UDI-Device Identifier: 05415067027283
• UDI-Public: (01)05415067027283(10)10669437(17)271231
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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 Model Number: D-AVSE-DF20-V1525
• Device Catalogue Number: D-AVSE-D10-V1525
• Device Lot Number: 10669437
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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