MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

Model Number G407209

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis; however, 3 images were submitted for evaluation.The images appear to show the stylet and a piece of the stylet within the heart under fluoroscopy.Visual inspection was based solely upon a review of the photographs received.The device met specifications prior to release from abbott manufacturing facilities as supported by a review of the device history record.The cause of the reported event remains unknown.

Event Description

During the procedure, the stylet detached into the patient's left atrium.While performing a transseptal puncture, the stylet was inserted into the needle and detached with 10 cm of the stylet remaining in the left atrium.Following the procedure, a lasso was used with fluoroscopy to retrieve the stylet from the heart.The procedure was completed with no adverse consequences to the patient.There was no performance issue with the reported brk needle.

• Brand Name: BRK-1¿ 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: 6811952
• MDR Text Key: 83293243
• Report Number: 3008452825-2017-00175
• 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: 08/22/2017

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: 02/29/2020
• Device Model Number: G407209
• Device Lot Number: 5910654
• Other Device ID Number: 05414734205184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• 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
• Patient Outcome(s): Required Intervention