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

Model Number 407200

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

Patient Problem Cardiac Perforation (2513)

Event Date 11/06/2017

Event Type  Injury  

Event Description

Related manufacturer reference: 3005334138-2017-00235; 9680001-2017-00094; 2182269-2017-00144.During a pulmonary vein isolation ablation procedure, a cardiac perforation occurred.After approximately five hours of ablation, the introducer was exchanged and a second transseptal puncture was performed.The patient became hypotensive and a pericardial effusion was noticed on the ice catheter and confirmed with an echocardiogram.No intervention was performed; the effusion resolved spontaneously and the patient was stabilized.There were no performance issues with any abbott devices.

Manufacturer Narrative

A cardiac perforation 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 cardiac perforation could not be conclusively determined.Per the ifu, cardiac perforation is a known risk with the use of this device.

• Brand Name: BRK¿ 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: 7072760
• MDR Text Key: 93390253
• Report Number: 3008452825-2017-00307
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 12/19/2017

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: 07/31/2020
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 6117287
• Other Device ID Number: 05414734205092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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: AGILIS STEERABLE INTRODUCER; SWARTZ BRD TRANS INTRO; TACTICATH QUARTZ CATHETER
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 80