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

Model Number D-AVSE-DF10-F20

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/08/2023

Event Type  malfunction  

Event Description

During the atrial fibrillation procedure, the advisor fl mapping catheter was used for post cryo ablation mapping.The advisor fl mapping catheter was inserted in a swartz braided introducer and then it was inserted into a non-abbott sheath (medtronic flexcath) to perform mapping.The advisor fl mapping catheter was then inserted back into the swartz braided introducer.When the advisor fl mapping catheter was removed from the patient's body, the catheter coating was broken and the lead wire was exposed.The advisor fl mapping catheter was replaced and since the damaged capsule remained in the swartz braided introducer, it was also replaced.The procedure then proceeded with no adverse patient consequences.There were no alleged issues with the swartz braided introducer.A post-operative mri was completed, and no residual findings were found in the cerebral blood vessels.Although it cannot be sure, found that what appeared to be remnants in the right atrium.The patient is currently under follow-up observation.A check of the sheath at this time revealed no external damage.There was no resistance during the procedure, and the user did not force the operation.

Manufacturer Narrative

One 20mm loop, bi-directional, curve d-f, sensor enabled, advisor fl circular mapping catheter was received for evaluation.One image was also submitted to product performance engineering for evaluation.The loop internal components were exposed due to torn loop tubing.No other visual anomalies were noted.The aforementioned image shows damage matching the damage found during the investigation.Device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damage remains unknown.

• Brand Name: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: ELECTRODE RECORDING CATHETER
• 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: 17849323
• MDR Text Key: 325085597
• Report Number: 3008452825-2023-00434
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067025968
• UDI-Public: 05415067025968
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160335
• 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: 11/28/2023

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 Expiration Date: 10/31/2023
• Device Model Number: D-AVSE-DF10-F20
• Device Lot Number: 8474876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/30/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2022
• 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