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

Model Number EP003994S

Device Problems Use of Device Problem (1670); Defective Device (2588)

Patient Problem Pericardial Effusion (3271)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.This report will capture the information for case #(b)(6), as referenced in the article.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿transseptal puncture facilitated by ¿reverse tenting¿ using a left atrial ablation catheter.¿ heartrhythm case reports.2019; 5(3):159-162.Doi: 10.1016/j.Hrcr.2018.12.002.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed which contained information regarding this transseptal needle.The article reported that there was one patient who was referred for left atrial catheter ablation.During the procedure, upon removal of the needle, it was noted that is ¿dropped¿ into a depression in the right atrium of the heart.The author noted that the operator applied a large amount of pressure, leading to a possible procedural error, which then led to pericardial effusion.The needle was removed.The procedure was aborted, and anti-coagulation reversal was needed promptly.The patient had no further issues, and the patient returned six weeks later for a repeat procedure.The second procedure has the same issue; even though a needle with less curvature was used.After three attempts, it was decided to use radio frequency for the procedure.The status/location of the needle is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

• Brand Name: BROCKENBROUGH NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9998586
• MDR Text Key: 188979090
• Report Number: 2182208-2020-00807
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2020

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?: Yes
• 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: 04/13/2020
• Initial Date FDA Received: 04/24/2020
• 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; Life Threatening; Required Intervention
• Patient Age: 67 YR