MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY COMFORTGRIP, BID, MED SWEEP, 4MM; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A-TCG-402819

Device Problems Bent (1059); Unintended Movement (3026)

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)

Event Date 03/21/2018

Event Type  Injury  

Event Description

During a case of concealed left accessory pathway reentry tachycardia, st segment elevation occurred.During the procedure the catheter was advanced into the left atrium via retro-aortic access.While guiding the catheter in the left ventricle to reach the mitral valve there was a movement of the catheter tip and at that moment the patient began to feel chest pain.The patient became hypotensive and st segment elevation on ecg was noted.Echocardiography and coronarography were performed to confirm there was no embolus or ischemia.The chest pain gradually decreased and st segment returned to a normal level with no intervention required.When the patient became stable the procedure was cancelled.The device was inspected upon removal and a bend was noted at the catheter tip.

Manufacturer Narrative

Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.The correct mfr number is 2182269.One therapy comfortgrip catheter was returned for an evaluation.Upon visual inspection a bend was noted near the distal tip.During electrical and temperature testing electrodes 1-4 and the thermistor/thermocouple met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend is consistent with damage during use.The cause of the reported arrhythmia could not be conclusively determined.

• Brand Name: THERAPY COMFORTGRIP, BID, MED SWEEP, 4MM
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 7433687
• MDR Text Key: 105586499
• Report Number: 2030404-2018-00030
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040042
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: A-TCG-402819
• Device Lot Number: 6220642
• Other Device ID Number: 05415067029119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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
• Patient Outcome(s): Other