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

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

Patient Problems Hemothorax (1896); Occlusion (1984); Perforation (2001); Cardiac Tamponade (2226)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

Lit ref: doi.Org/10.1007/s00270-018-2090-1.If information is provided in the future, a supplemental report will be issued.

Event Description

123 patients underwent sharp recanalization of chronic venous occlusions.Medtronic brockenborough transeptal needle was amongst the devices used.Technical success was achieved in 111 (90.2%) patients.There were 3 (2.4%) severe, 1 (0.8%) moderate, and 7 (5.7%) minor adverse events.Severe adverse events included 1 case each of pericardial tamponade, hemothorax, and inferior vena cava filter occlusion.Specifically, in 1 (0.8%) procedure, there was perforation of the right brachiocephalic vein with resulting right hemothorax during a successful recanalization of an occluded right jugular vein with a transseptal needle and loop snare, managed with placement of a 10 mm 9 4 cm non-medtronic stent and uncomplicated placement of chest tube.In 1 (0.8%) procedure, there was re-occlusion of the inferior segment of the patient¿s already-present inferior vena cava filter after successful sharp recanalization of an occluded right ilio-caval confluence, which was treated successfully with pharmacomechanical thrombolysis.There were 7/123 (5.7%) minor adverse events, which included 4 (3.3%) cases of self-limited retroperitoneal extravasation and 1 (0.8%) case each of self-contained extravasation into the mediastinum, pelvis, and left upper arm.

• 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: 8455157
• MDR Text Key: 139959505
• Report Number: 1220452-2019-00035
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2019

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: 03/11/2019
• Initial Date FDA Received: 03/27/2019
• 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: 51 YR