MAUDE Adverse Event Report: ST. JUDE MEDICAL 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 Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  malfunction  

Event Description

During a pulmonary vein isolation ablation procedure, resistance was noted when inserting the catheter and the device could not be advanced past the hemostasis valve of the sheath.Upon removal from the patient, the distal electrode was separated from the catheter.The catheter was replaced and the procedure was completed with no adverse consequences onto the patient.

Manufacturer Narrative

One 15 mm loop, bi-directional, curve d-f, sensor enabled, advisor fl circular mapping catheter was received for evaluation.The distal electrode was noted to be dislodged from the grey shaft material, exposing the base of the distal electrode assembly.No other visual anomalies were noted.The cause of the partially separated tip electrode and the reported insertion difficulty is consistent with not using the tip straightener to straighten the loop during insertion of the catheter into the introducer sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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; 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: 7604810
• MDR Text Key: 111150126
• Report Number: 3005334138-2018-00159
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067025975
• UDI-Public: 05415067025975
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/31/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: D-AVSE-DF10-F15
• Device Lot Number: 6317177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• 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