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

Model Number	D-AVSE-DF10-F20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
During a pulmonary vein isolation procedure a clinically signification delay occurred.During left atrial geometry collection the advisor catheter was advanced into the left ventricle and became entangled in the mitral valve.The catheter was difficult to remove once entangled and took an hour until the tip of the catheter was released and pulled back into the atrium.The patient experienced no adverse consequences to the mitral annulus and the procedure was completed with a catheter replacement.
Additional Manufacturer Narrative
One sensor enabled, advisor fl circular mapping catheter, was received for evaluation.Microscopic inspection of the catheter loop revealed twisting and stretching of the gray loop material, consistent with damage sustained during the reported withdrawal difficulty.The advisor fl circular mapping catheter instructions for use contraindicates, ¿this device is not recommended for use in the ventricles." the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the withdrawal difficulty remains unknown.The cause of the spiral loop damage is consistent with damage during 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, 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
• MDR Report Key: 7674020
• Report Number: 3008452825-2018-00228
• Device Sequence Number: 19174846
• Product Code: DRF
• UDI-Device Identifier: 05415067025968
• UDI-Public: 05415067025968
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K160335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: D-AVSE-DF10-F20
• Device Lot Number: 6419630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR