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-D10-F15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During the procedure, electrode one ruptured while being removed from the introducer.Another catheter was used to continue the procedure with no consequences to the patient.
Additional Manufacturer Narrative
One 15mm loop, uni-directional, curve d, sensor enabled, advisor fl circular mapping catheter was received for evaluation.Visual inspection confirmed the distal tip of the catheter was fractured and detached.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured and detached distal tip 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: 10437136
• Report Number: 3008452825-2020-00436
• Device Sequence Number: 2676022
• Product Code: DRF
• UDI-Device Identifier: 05415067024800
• UDI-Public: 05415067024800
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 04/30/2021
• Device Model Number: D-AVSE-D10-F15
• Device Catalogue Number: D-AVSE-D10-F15
• Device Lot Number: 7284620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1