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

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.

• Brand Name: UNKNOWN BEACON NEEDLE
• Type of Device: MARKER, 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 Key: 10574198
• MDR Text Key: 208164286
• Report Number: 3004904811-2020-00030
• 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: Other
• 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 Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN BEACON NEEDLE
• Device Catalogue Number: UNKNOWN BEACON NEEDLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2020
• 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; Required Intervention
• Patient Age: 52 YR