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

Model Number A701128

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

Patient Problem Cardiac Perforation (2513)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was unable to be reviewed since the batch number is unknown.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturing reference: 3005188751-2015-00093, 3005188751-2015-00094.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Transseptal puncture was performed using a sl0 sheath and a non sjm needle.The swartz sl0 sheath was exchanged for a swartz sl2 sheath and a flexibility catheter was advanced for the procedure.While mapping and ablating in the left atrium the patient became hypotensive.An echocardiogram was performed with no effusion noted.Approximately one hour later, another echocardiogram was performed which revealed an effusion.A pericardiocentesis was performed which stabilized the patient.There were no performance issues with any sjm devices.

Event Description

Additional information received indicated the pericardial effusion was caused by a non sjm needle.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE F-J
• 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: 5012053
• MDR Text Key: 23383825
• Report Number: 3005334138-2015-00089
• 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
• Type of Report: 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 Model Number: A701128
• Device Catalogue Number: A701128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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