MAUDE Adverse Event Report: MEDTRONIC, INC BROCKENBROUGH NEEDLE; TROCAR

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

Patient Problems Perforation (2001); Patient Problem/Medical Problem (2688)

Event Date 02/20/2015

Event Type  Injury  

Manufacturer Narrative

Catheterization and cardiovascular interventions aortic iatrogenic perforation during transseptal puncture and successful occlusion with amplatzer ductal.

Event Description

It is reported that during a procedure the aortic root was forcefully punctured with a brockenbrough needle.Catheterization was performed.The atrial septum was thicker than normal and no stent was visualized.The brockenbrough needle slipped from de fossa ovalis and, inadvertently the aortic root was forcefully punctured.An 8-fr mullins sheath was immediately advanced following the puncture.It was decided to leave the 8-fr sheath in the aortic root recognizing the danger of removing the sheath.Finally a 6/4 mm non-medtronic ductal occluder was advanced through the mullins sheath and under fluoroscopy and tee guidance, a successful deployment of the device and closure of the perforation was achieved.Subsequently, the paravalvular leak was closed with an non-medtronic vascular plug.The physician assessed that the perforation was because of a mistake by the surgical team, and the patient anatomy never contributed to the 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, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5547163
• MDR Text Key: 41850442
• Report Number: 1220452-2016-00019
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• 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
• Patient Age: 00048 YR
• Patient Weight: 65