MAUDE Adverse Event Report: PERFUSION SYSTEMS BROCKENBROUGH NEEDLE; TROCAR

Model Number EP003994S

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

Patient Problems Death (1802); Cardiac Tamponade (2226); Blood Loss (2597); Pericardial Effusion (3271)

Event Date 01/01/2016

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: product id: ep008591.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The gender of the baseline characteristics is male and the baseline age is 77 years old.Without a lot number or device serial number, the manufacturing date cannot be determined.The date of death is not available at the time of this report; as there is no indication of specific lot number/patient information.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: "the evolving role of left atrial appendage occlusion.¿ kardiovaskulare medizin.2016; 19 (11): 288-295.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed which contained information regarding experiences with percutaneous left atrial appendage occlusion (laao).This report is specifically while using a transeptal sheath and needle.The article indicated that there was a patient death, and per the author, the ¿potential causes might have been manipulations of the transseptal needle or it might have occurred during surgery.¿ of note, the patient underwent a combined intervention; the laao was ¿successful ,¿ and then the patient had a mini-thoracotomy for single bypass surgery.This procedure revealed a pericardial effusion/tamponade.The right ventricle had been perforated.It was also noted that the patient remained stable throughout all of the interventions.An emergency sternotomy was performed, and the ventricle was sutured.The patient also underwent ¿successful¿ bypass surgery but could not be taken off the heart-lung machine.Further complications, such as clotting and bleeding, occurred, and the patient expired on the day of surgery.The status/disposition of the devices is unknown.Further follow up did not yet yield any additional information.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was obtained through follow up with the author who indicated that the death was "not related to a medtronic product." no further information was provided.

• Brand Name: BROCKENBROUGH NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8413807
• MDR Text Key: 138587923
• Report Number: 2184009-2019-00007
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 03/26/2019
• 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
• Treatment: MULLINS SHEATH
• Patient Outcome(s): Death
• Patient Age: 77 YR