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

Model Number DSC-22-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Vomiting (2144); Pancreatitis (4481)

Event Type  Injury  

Manufacturer Narrative

Title: ath-04 comparing the diagnostic yield and safety of endosonography guided use of shark-core and pro-core needles; 2019 source: 10.1136/gutjnl-2019-bsgabstracts.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, a total of 143 patients having 151 pancreatic lesions were analyzed.69 patients used shark-core while 74 patients used pro-core.74 lesions were biopsied in shark-core group from 69 patients.Four patients had their procedure repeated.2 patients developed mild pancreatitis and one required admission with epigastric pain and vomiting.

• Brand Name: SHARKCORE
• Type of Device: BIOPSY NEEDLE
• 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: 12744450
• MDR Text Key: 279806246
• Report Number: 3004904811-2021-00016
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00855208005087
• UDI-Public: 00855208005087
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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
• Date Manufacturer Received: 10/13/2021
• 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