MAUDE Adverse Event Report: ST JUDE MEDICAL TRANSEPTAL NEEDLE; TROCAR

Model Number 407200

Device Problems Bent (1059); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2013

Event Type  malfunction  

Event Description

During attempted transeptal puncture, md noticed more resistance that usual during the procedure.Transeptal needle removed from patient.Md noticed a more acute bend to the product than usual.

• Brand Name: TRANSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST JUDE MEDICAL; 1 st jude medical dr.; st paul MN 55117
• MDR Report Key: 4736970
• MDR Text Key: 5768727
• Report Number: 4736970
• Device Sequence Number: 1
• Product Code: DRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Device Lot Number: 4132434
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2015
• Patient Sequence Number: 1
• Patient Age: 55 YR