MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY? DUAL-8? ABLATON CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number IBI-83424

Device Problem Difficult To Position (1467)

Patient Problem Complete Heart Block (2627)

Event Date 01/15/2015

Event Type  Injury  

Event Description

During a cavotricuspid isthmus (cti) ablation using a therapy ablation catheter, third degree complete heart block occurred.During ablation at the cti with a therapy ablation catheter, two episodes of twenty second compete heart block occurred without patient symptoms.The patient's intrinsic sinus rhythm returned after the right ventricular apex was paced for a few minutes and no further intervention was needed.Incorrect deflection of the catheter was noted.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).One 7f, quadripolar, therapy dual-8 steerable ablation catheter was received for evaluation.A bend was noted in the distal shaft and between electrode 2 and 3.The catheter shaft no longer met curve specifications when deflected and undeflected due to bends in the shaft.The device met specifications prior to release from sjm manufacturing facilities as supported by a review of the device history record.The cause of the bends in the shaft is consistent with damage during use and the cause for third degree complete heart block remains unknown.

• Brand Name: THERAPY? DUAL-8? ABLATON CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4511795
• MDR Text Key: 5530485
• Report Number: 2030404-2015-00010
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: IBI-83424
• Device Lot Number: 4365731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2013
• 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): Required Intervention