MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION¿ SPIRAL BI-DIRECTIONAL VARIABLE RADIUS CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D402893

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Event Description

During a cryo-ablation procedure, electrode 4 detached from the catheter.During the procedure the catheter was placed in the pulmonary vein and was removed following cryo-ablation for additional mapping.Resistance was noted during removal.Prior to re-insertion into the patient detachment of the 4th electrode was noted.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation concluded that electrode 4 had been detached from the spiral loop.As a result, actions to prevent reoccurrence have been implemented.

Manufacturer Narrative

The reported detached electrode was confirmed.Electrode 4 was detached from the spiral loop and electrode 3 was displaced.The cause for the detached and displaced electrodes was due to an inadequate fixture during assembly.

• Brand Name: REFLEXION¿ SPIRAL BI-DIRECTIONAL VARIABLE RADIUS CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7320101
• MDR Text Key: 101725881
• Report Number: 2182269-2018-00041
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072012
• 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,Followup
• Report Date: 10/03/2018

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: 08/31/2020
• Device Model Number: D402893
• Device Catalogue Number: D402893
• Device Lot Number: 6096269
• Other Device ID Number: 05414734216654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 09/13/2018
• Supplement Dates FDA Received: 05/01/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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: BRAIDED SWARTZ INTRODUCER; MEDTRONIC FLEXCATH ADVANCE