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

Catalog Number UNK-CV-DAN-BROCKEN

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

Patient Problem Perforation (2001)

Event Date 11/22/2014

Event Type  Injury  

Manufacturer Narrative

Journal title: transseptal access in pediatric and congenital electrophysiology procedures: defining risk authors: johannes c.Von alvensleben <(>&<)> macdonald dick ii <(>&<)> david j.Bradley <(>&<)> martin j.Lapage reference: j interv card electrophysiol (2014) 41:273¿277 doi 10.1007/s10840-014-9946-3.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

During a cardiac catheter ablation procedure which was achieved by transseptal puncture (tsp) using the brockenbrough procedure, needle perforation of the posterior wall of the left atrium occurred.Femoral venous sheath access was used.Contrast was injected and opacified the pericardial space.The dilator and sheath were not advanced and the needle was withdrawn.The case was completed successfully through a second tsp site.

• 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: 6431353
• MDR Text Key: 70766305
• Report Number: 1220452-2017-00021
• 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: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-DAN-BROCKEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• 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
• Patient Age: 15 YR