MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SUPREME¿ ELECTROPHYSIOLOGY CATHETER, HEXAPOLAR, 120 CM LENGTH, CRD-2¿ CURVE, ELE; DIAGNOSTIC EP CATHETER

Model Number 402010

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 12/04/2017

Event Type  Injury  

Event Description

During a supraventricular tachycardia procedure, the catheter was removed from the patient and tissue was noted on the tip electrode.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

Event Description

Difficulty was noted when introducing the catheter.After the procedure, the catheter was removed from the patient and tissue was noted on the tip electrode.

Manufacturer Narrative

The investigation confirmed a silicone and a biological foreign material was noted on the distal tip of the catheter.Silicone is not used in the manufacturing process concluding the material was not from an abbott device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.It remains unknown the origin of the silicone material that was removed from the tip of the device.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, HEXAPOLAR, 120 CM LENGTH, CRD-2¿ CURVE, ELE
• Type of Device: DIAGNOSTIC EP 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: 7144517
• MDR Text Key: 95719409
• Report Number: 2182269-2017-00152
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002976
• 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: 04/13/2018

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: 03/31/2020
• Device Model Number: 402010
• Device Lot Number: 5940530
• Other Device ID Number: 05414734202022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 02/20/2018; 03/16/2018
• Supplement Dates FDA Received: 02/22/2018; 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• 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