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-F15
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in a subsequent submission.
Event or Problem Description
During a pulmonary vein isolation procedure a device fragmentation occurred.The catheter was inserted into the left atrium (la) via a 9f introducer with minimal resistance and after the la model was completed the catheter was smoothly retracted into the sheath for removal.Though no resistance was noted it appeared that part of the catheter had detached when it was retracted back into the sheath.When the catheter was outside of the body it was confirmed the end with the electrodes was missing.A new catheter was introduced into the patient through the left femoral vein to continue the procedure.There were no adverse consequences to the patient however the detached portion of the catheter remains within the patient with plans to remove in a couple months.
Additional Manufacturer Narrative
One 15mm loop, bi-directional, curve d-f, sensor enabled, advisor fl circular mapping catheter was received for evaluation and two images were received.The images appear to show the distal tip of the catheter with a detached tip as well as an x-ray of the detached component.The distal tip was detached proximal to the distal loop transition.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detached distal tip remains unknown.

• 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: 8871696
• Report Number: 3008452825-2019-00394
• Device Sequence Number: 1811956
• Product Code: DRF
• UDI-Device Identifier: 05415067025975
• UDI-Public: 05415067025975
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 12/17/2019

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: 06/30/2020
• Device Model Number: D-AVSE-DF10-F15
• Device Lot Number: 6828121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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