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

Model Number DSC-22-01

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Radiation Exposure, Unintended (3164)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

Title endoscopic ultrasound-guided biopsy in chronic liver disease: a randomized comparison of 19-g fna and 22-g fnb needles source endoscopic ultrasound-guided biopsy endoscopy international open, volume 07, 2019 (e62-71) date of publication: 6 november 2018.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to the literature source of study performed 2018, the patient underwent initial esophageal upper sphincter guided liver biopsy using to different needles.The patient experienced pain after the procedure but was discharged without pain.After one day of the procedure.During a follow-up call, the patient reports pain and was instructed to go to the emergency department.The laboratory testing showed stable hemoglobin and the ct scan showed no visible hemorrhage, perforation or abscess.The patient was sent home and did not report pain during the 7 day follow-up call.

• 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: 8639307
• MDR Text Key: 146049653
• Report Number: 3004904811-2019-00019
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00855208005087
• UDI-Public: 00855208005087
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DSC-22-01
• Device Catalogue Number: DSC-22-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2019
• 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): Required Intervention
• Patient Age: 51 YR