MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH

Model Number G407211

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

Patient Problems Stroke/CVA (1770); Cardiac Perforation (2513)

Event Date 04/25/2018

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 reviewed to ensure that each manufacturing and inspection operation was performed.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 manufacturer reference: 3005334138-2018-00136, 3005334138-2018-00137, 3008452825-2018-00160, 2182269-2018-00072.During an atrial tachycardia ablation procedure, a pericardial effusion occurred.Following the procedure, a routine echocardiogram revealed no pericardial effusion.However, hours after the procedure, the patient became hypotensive and another echocardiogram confirmed a pericardial effusion for which a pericardiocentesis was performed to stabilize the patient.The heparin injection was halted and protamine was administered.The following day, the heparin injection resumed.The second day following the procedure, the patient suffered a stroke and left hemiplegia.There were no performance issues with any abbott device during the procedure.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7538433
• MDR Text Key: 109060560
• Report Number: 3008452825-2018-00161
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2018

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: 01/31/2021
• Device Model Number: G407211
• Device Lot Number: 6330493
• Other Device ID Number: 05414734205153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2018
• 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: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SE; AGILIS¿ NXT STEERABLE INTRODUCER; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR