MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

Model Number G407208

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2017

Event Type  Injury  

Manufacturer Narrative

A pericardial effusion was reported.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: 3008452825-2017-00324, 3005334138-2017-00250, 3008452825-2017-00325, 3005334138-2017-00251, 9680001-2017-00102.Following a pulmonary vein isolation ablation procedure, a pericardial effusion occurred.After the left veins were isolated, the transseptal access was lost.There were difficulties in locating the previous access site and during this time, the catheter appeared outside of the geometry.The catheter was difficult to maneuver and when the catheter was pushed to the left lateral wall it still appeared outside of the geometry.A contrast was injected but the catheter did not appear to be in the pericardium.The catheter was moved back into the right atrium and the transseptal puncture was performed again.The procedure was completed with no further issues.After the procedure, an echocardiogram was performed revealing the pericardial effusion.A pericardiocentesis was performed to stabilize the patient.The patient remained asymptomatic during and after the procedure.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 71 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; 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: 7118424
• MDR Text Key: 94879122
• Report Number: 3008452825-2017-00326
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: G407208
• Device Lot Number: 6108398
• Other Device ID Number: 05414734205139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• 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: 1910-SA 10-PIN DIAGNOSTIC CONNECTING CABLE; ADVISOR¿ CATHETER, SENSOR ENABLED¿; ADVISOR¿ CONNECTION CABLE 12 POLE; COOL POINT¿ IRRIGATION PUMP TUBING SET; INQUIRY¿ CATHETER; SENSITHERM¿ PROBE; SWARTZ¿ BRAIDED INTRODUCER; SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER,; TACTICATH¿ CATHETER; XENETIX 300 100 ML
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 91