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

Model Number IBI-83562

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

Patient Problem Arrhythmia (1721)

Event Date 09/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported st elevation and chest pain could not be conclusively determined.

Event Description

During a ventricular tachycardia ablation procedure, chest pain with st elevation occurred.A therapy cool path duo ablation catheter was introduced to the left ventricle vie retrograde access.Geometry was created and the ablation catheter was placed in the left ventricular apex, at which time the catheter impedance increased and the distal end of the catheter displayed out of geometry.A few minutes later the patient complained of chest pain and st elevation was noted on the ekg.An echocardiogram revealed no pericardial effusion and a coronary angiogram revealed no infarction.The physician indicated the cause of the st elevation may have been due to a cardiac perforation at the left ventricular apex, a coronary artery spasm, or an air embolus, none of which could be confirmed.The patient was stable.

• 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: 5138407
• MDR Text Key: 27918257
• Report Number: 2030404-2015-00074
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/09/2015

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
• Device Expiration Date: 12/31/2017
• Device Model Number: IBI-83562
• Device Lot Number: 4948013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• 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
• Patient Age: 64 YR
• Patient Weight: 82