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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in a subsequent submission.

Event 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into the sheath for removal.Though no resistance was noted it appeared that part of the catheter had detached when it was retracted back into the sheath.When the catheter was outside of the body it was confirmed the end with the electrodes was missing.A new catheter was introduced into the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.

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¿
• Type of Device: 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
• MDR Text Key: 153602691
• Report Number: 3008452825-2019-00394
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067025975
• UDI-Public: 05415067025975
• Combination Product (y/n): N
• PMA/PMN Number: K160335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other