• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BARRX UNKNOWN BEACON NEEDLE MARKER, RADIOGRAPHIC, IMPLANTABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN LP BARRX UNKNOWN BEACON NEEDLE MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number UNKNOWN BEACON NEEDLE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/23/2020
Event Type  Injury  
Manufacturer Narrative
Title: the bleeding risk after endoscopic ultrasound guided puncture of pancreatic masses source: scandinavian journal of gastroenterology, 56:2, 205-210, doi: 10. 1080/00365521. 2020. 1863458. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source of study performed between february 2017 and september 2019 in klinikum klagenfurt hospital and between november 2018 and september 2019 in university hospital st. Polten, a total of 187 patients underwent 202 eus guided fine needle aspiration /fine needle biopsy nb procedures (141 for solid and 61 for cystic pancreatic masses. ) their aim was to compare bleeding rate. One adverse event occurred on a patient without comorbidities and antithrombotic therapy encountered a major bleed during the eus-fine needle biopsy of a mass in the head of the pancreas using a 19g needle. The arterial bleed was controlled by applying a hemoclip through the echoendoscope. A hemoclip was placed and the bleeding stopped immediately. The patient remained hemodynamically stable presented with hemoglobin drop of 2. 8g/dl and was discharged one day later.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN BEACON NEEDLE
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
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 Key12166461
MDR Text Key261474618
Report Number3004904811-2021-00009
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN BEACON NEEDLE
Device Catalogue NumberUNKNOWN BEACON NEEDLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/14/2021 Patient Sequence Number: 1
-
-