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

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.

• Brand Name: SHARKCORE
• Type of Device: KIT, 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 Key: 8410041
• MDR Text Key: 138456688
• Report Number: 3004904811-2019-00008
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00855208005131
• UDI-Public: 00855208005131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• 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 Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2020
• Device Model Number: DSL-19-01
• Device Catalogue Number: DSL-19-01
• Device Lot Number: B000000617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2019
• 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: 45 YR
• Patient Weight: 73