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

Model Number D-AVSE-D10-F20

Device Problem Difficult to Remove (1528)

Patient Problems Cardiac Perforation (2513); Device Embedded In Tissue or Plaque (3165)

Event Date 04/04/2017

Event Type  Injury  

Event Description

During a mapping procedure, the catheter became entangled in the patient¿s mitral valve.When attempting to free the catheter from the entanglement, the distal portion of the spiral separated from the catheter and remained in the mitral valve.Additional surgery was performed to extract the catheter, and the patient¿s mitral valve was replaced.The patient was in stable condition following the procedure.

Manufacturer Narrative

The results of the investigation concluded the spiral loop of the catheter was separated from the distal shaft.Further investigation revealed that significant force was required to separate the loop from the deflectable shaft.The cause of the loop separation is consistent with damage during use.Review of the event revealed that this device was used in a left vt ablation procedure; the advisor fl circular mapping catheter, sensor enabled instructions for use contraindicates use of the device in the left ventricle.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Event Description

A pericardial effusion was noticed upon removal of the catheter.A pericardiocentesis was performed to stabilize the patient prior to the mitral valve replacement.

• Brand Name: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6540559
• MDR Text Key: 74296421
• Report Number: 3005334138-2017-00038
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K160335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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: 04/30/2018
• Device Model Number: D-AVSE-D10-F20
• Device Lot Number: 5753466
• Other Device ID Number: 05415067024817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 110