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

Model Number	DSC-22-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: comparing needles and methods of endoscopic ultrasound-guided fine-needle biopsy to optimize specimen quality and diagnostic accuracy for patients with pancreatic masses in a randomized trial.Source: journal pre-proof to appear in: clinical gastroenterology and hepatology accepted date: 17 june 2020.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed september 2019 and december 2019, patients found to have pancreatic masses during imaging were randomly assigned to groups from whom pancreatic tissue samples were collected using reverse-bevel, menghini-tip, franseen and gauge 22 fork-tip needles.The patient had post-procedure abdominal pain which required an emergency room visit.

• 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: 10411902
• Report Number: 3004904811-2020-00023
• Device Sequence Number: 2898769
• Product Code: FCG
• UDI-Device Identifier: 00855208005087
• UDI-Public: 00855208005087
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2020

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 Model Number: DSC-22-01
• Device Catalogue Number: DSC-22-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/16/2020
• 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: Required Intervention
• Patient Age: 64 YR