MAUDE Adverse Event Report: COVIDIEN LP BARRX UNKNOWN BEACON

Model Number UNKNOWN BEACON

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

Patient Problems Bacterial Infection (1735); Septic Shock (2068); Blood Loss (2597); No Code Available (3191)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed (july 2010 to february 2018), to evaluate the safety and infection risk associated with endoscopic ultrasound guided fiducial placement for pancreatobiliary malignancies and used of peri procedural prophylactic antibiotics.7 patient's developed severe procedural adverse event.Three patients developed acute pancreatitis, one patient had major bleeding requiring blood transfusion after eus-guided fiducial placement, one patient developed acute cholangitis, one patient developed bacteremia and one patient developed septic shock.

• Brand Name: UNKNOWN BEACON
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer (Section G): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9857102
• MDR Text Key: 192171054
• Report Number: 3004904811-2020-00003
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN BEACON
• Device Catalogue Number: UNKNOWN BEACON
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2020
• 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): Life Threatening; Required Intervention