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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BARRX SHARKCORE KIT, NEEDLE, BIOPSY

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COVIDIEN LP BARRX SHARKCORE KIT, NEEDLE, BIOPSY Back to Search Results
Model Number DSL-19-01
Device Problem Difficult to Remove (1528)
Patient Problems Fever (1858); Hepatitis (1897); Internal Organ Perforation (1987); Pain (1994); Pneumonia (2011); Radiation Exposure, Unintended (3164)
Event Date 02/05/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the patient had a stomach perforation during liver biopsy, attempted to reach the right lobe and once perforated, the air entered into the stomach. There were 3 passes targeting liver parenchyma as well as the lesion. The patient experienced mild pain post procedure and increased pain the following day. A computed tomography (ct) scan abdomen performed showed a substantial amount of free air/pneumoperitoneum. The patient was put on antibiotics and after 7 days course of antibiotic, the patient still had a fever. Another ct scan was performed as an outpatient which appeared to have atelectasis/possible pneumonia in lung base and the patient was admitted for about a day and another antibiotic was started. Patient was discharged approximately 1 day after admission. The physician also noted that at the end of the procedure, there was some difficulty or resistance with the needle removal and had the difficulty with gliding. The physician stated that the needle did not bend. There was no injury or harm to the physician.
 
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Brand NameSHARKCORE
Type of DeviceKIT, NEEDLE, BIOPSY
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 Key8410041
MDR Text Key138456688
Report Number3004904811-2019-00008
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141898
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/04/2020
Device Model NumberDSL-19-01
Device Catalogue NumberDSL-19-01
Device Lot NumberB000000617
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2019
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: 03/11/2019 Patient Sequence Number: 1
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