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U.S. Department of Health and Human Services

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

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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 Problems Abdominal Pain (1685); Hematoma (1884); Blood Loss (2597); Unintended Radiation Exposure (4565)
Event Date 04/09/2020
Event Type  Injury  
Manufacturer Narrative
Title: eus-guided fine-needle core liver biopsy with a modified one-pass, one-actuation wet suction technique comparing two types of eus core needles. Source: endoscopy international open 2020; 08: e938¿e943 published online: 2020-06-16. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source of the retrospective study performed between 2015 and 2018, the liver biopsy using the company's device has been associated with abdominal pain in 35 patients (17%) immediately post-procedure. Two patients required intravenous (iv) narcotic administration for a total of. 5mg and 1mg in each patient, respectively for pain. In addition, sub capsular hematomas developed in one patient (0. 5%). The hematoma measured 2. 5 cm by 3. 5cm on abdominal computed tomography. The patient was admitted overnight for pain control and received 1 unit of packed red blood cell transfusion. The hematoma resolved on follow up abdominal imaging 1 month later.
 
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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 Key10574198
MDR Text Key208164286
Report Number3004904811-2020-00030
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
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 Received09/04/2020
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: 09/23/2020 Patient Sequence Number: 1
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