MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION¿ SPIRAL VARIABLE RADIUS CATHETER 6F LOOP BI-DIRECTIONAL; CATHETER, ELECTRODE RECORDING

Model Number D402893

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Complaint, Ill-Defined (2331); Pericardial Effusion (3271)

Event Date 04/02/2015

Event Type  Injury  

Event Description

Related manufacturer reference 3005334138-2015-00048, 3005334138-2015-00049 , 3008452825-2015-00023.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.While ablating the mitral isthmus, the patient became hypotensive and fluoroscopy showed decreased cardiac movement.An echocardiogram revealed a pericardial effusion and a pericardiocentesis was performed which stabilized the patient.There were no performance issues noted with any sjm device used.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received indicated this device did not contribute to the cardiac perforation.

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 pericardial effusion was procedure related.Per the ifu, cardiac perforation is a known risk during use of this device.

• Brand Name: REFLEXION¿ SPIRAL VARIABLE RADIUS CATHETER 6F LOOP BI-DIRECTIONAL
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4736270
• MDR Text Key: 17629953
• Report Number: 3005188751-2015-00045
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072012
• 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,Followup
• Report Date: 04/02/2015

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: D402893
• Device Lot Number: 4932588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 04/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2015
• 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
• Treatment: INQUIRY STEERABLE EP CATHETER; TACTICATH QUARTZ ABLATION CATHETER; SWARTZ BRAIDED TRANSSEPTAL INTRODUCER
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 82