MAUDE Adverse Event Report: MEDTRONIC MEXICO BROCKENBROUGH NEEDLE; TROCAR

Model Number EP003994S

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

Patient Problems Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): product id: ep008591.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a radiofrequency (rf) procedure, when the transeptal puncture was perform from the right to the left atrium, a pericardial effusion and perforation occurred in the left atrium "heart roof" as well as a cardiac tamponade.A pericardiocentesis was performed as well as heart surgery with a sternotomy.The hospitalization stay was extended.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: BROCKENBROUGH NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7677974
• MDR Text Key: 113666793
• Report Number: 9612164-2018-01689
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 10/03/2018

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 Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 60