MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-D; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A701124

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

Patient Problem Cardiac Perforation (2513)

Event Date 07/09/2015

Event Type  Injury  

Event Description

Related manufacturing reference: 3005188751-2015-00089, 3005188751-2015-00090.During a left side ablation procedure, a pericardial effusion occurred.Transseptal puncture was performed with a brk transseptal needle through a sl0 introducer.While mapping in the left ventricle with the flexibility ablation catheter, the patient became hypotensive and an echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed which stabilized the patient.There were no performance issues with any sjm devices.

Manufacturer Narrative

(b)(4).The results of 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 pericardial effusion could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-D
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4974740
• MDR Text Key: 15233991
• Report Number: 3005334138-2015-00087
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

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: 07/31/2015
• Device Model Number: A701124
• Device Catalogue Number: A701124
• Device Lot Number: 4738849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 08/05/2015
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2014
• 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
• Treatment: BRK NEEDLE; RESPONSE QUADRIPOLAR X 2; NAVX SYSTEM; RESPONSE DECAPOLAR CATHETER; SL0 INTRODUCER; COOLPOINT PUMP; IBI T11 GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR