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 07/30/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Cardiovascular revascularization medicine 2015 percutaneous treatment of an iatrogenic aorta-to-right atrium fistula.

Event Description

It is reported that the patient suffered accidental puncture of the aortic root by a brockenbrough needle and advancement of an 8 french mullins sheath during a mitral valve repair procedure.The patient remained haemodynamically stable, with no evidence of a pericardial collection on tte and the procedure was abandoned.The patient was managed conservatively and made an uneventful recovery and was discharged home after three days of observation.At follow-up it was noted that a significant aorta-to right atrium fistula had developed at the site of the previous aortic puncture.A duct occluder was implanted to treat the fistula.The patient made an uneventful recovery and was discharged after three days.6 month follow up confirmed no residual fistula.

• 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.; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5500046
• MDR Text Key: 40325014
• Report Number: 1220452-2016-00014
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PREAMENDMENT
• 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: 02/17/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/15/2016
• 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: 00065 YR