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

Model Number D-AVSE-DF10-F15

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  malfunction  

Event Description

During the procedure, the distal electrode became displaced when the catheter was inserted via an 8f sheath.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One sensor enabled, advisor fl circular mapping catheter was received for evaluation.Visual inspection revealed the distal electrode was dislodged from the grey shaft material, exposing the base of the distal electrode assembly.No other visual anomalies were noted.Further investigation revealed the cause of the partially separated tip electrode is consistent with not using the tip straightener to straighten the loop during insertion of the catheter into the introducer sheath.The advisor fl circular mapping catheter instructions for use (ifu), document states: ¿always straighten the catheter before insertion or withdrawal".The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that all manufacturing and inspection procedures were completed at the time of manufacture.

• 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: 7536332
• MDR Text Key: 108985110
• Report Number: 3005334138-2018-00133
• Device Sequence Number: 1
• Product Code: DRF
• 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: 07/12/2018

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: 03/31/2019
• Device Model Number: D-AVSE-DF10-F15
• Device Lot Number: 6162240
• Other Device ID Number: 05415067025975
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2017
• 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
• Treatment: SWARTZ INTRODUCER, 8F