MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complete Heart Block (2627)

Event Date 08/05/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported heart block could not be conclusively determined.

Event Description

During a supraventricular tachycardia ablation procedure, third degree heart block occurred.During the procedure, noise on the ablation catheter made the signals of the ibi cool path duo medium curve ablation catheter unrecognizable both on the ensite velocity and the ep-workmate.Troubleshooting revealed this was most likely due to grounding issues in the lab.The his bundle was not recognized and located, but the ablation catheter was placed at the bottom of the koch's triangle and ablation was initiated.The patient developed a slow junctional rhythm followed by third degree av block.Antiarrhythmic drugs were administered and the patient converted to sinus rhythm.

• Brand Name: THERAPY¿ COOL PATH¿ DUO ABLATION 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: 5056744
• MDR Text Key: 25025190
• Report Number: 2030404-2015-00065
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/05/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EP WORKMATE RECORDING SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 75