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

Model Number	DSL-19-01
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Fever (1858); Hepatitis (1897); Internal Organ Perforation (1987); Pain (1994); Pneumonia (2011); Radiation Exposure, Unintended (3164)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 8410041
• Report Number: 3004904811-2019-00008
• Device Sequence Number: 389354
• Product Code: FCG
• UDI-Device Identifier: 00855208005131
• UDI-Public: 00855208005131
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 73