MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA ADVISOR¿ VL, SENSOR ENABLED¿ CIRCULAR MAPPING CATHETER; ELECTRODE RECORDING CATHETER

Model Number	D-AVSE-D10-V1525
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrilation procedure, it was noted that the catheter was difficult to rotate during the modeling process.The catheter was withdrawn from the heart and the front end of the catheter was fractured.The device was replaced, and the procedure was completed with no adverse consequences to the patient.There was no noticeable abnormality of the catheter after opening the package.
Additional Manufacturer Narrative
One 10 pole, uni-directional, curve d, sensor enabled, advisor vl circular mapping catheter was received for evaluation.Two images were also submitted to product performance engineering for evaluation.Visual inspection revealed the shaft material was torn between electrode 5 and 6 and internal components were exposed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn shaft and exposed wires remain unknown.

• Brand Name: ADVISOR¿ VL, SENSOR ENABLED¿ CIRCULAR MAPPING CATHETER
• Common Device Name: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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, COSTA RICA LTDA; 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; af_productsurveillance@abbott.com; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17417731
• Report Number: 3008452825-2023-00328
• Device Sequence Number: 7144562
• Product Code: DRF
• UDI-Device Identifier: 05415067027252
• UDI-Public: 05415067027252
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: 02/28/2026
• Device Model Number: D-AVSE-D10-V1525
• Device Lot Number: 8949724
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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