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

Model Number	DSC-25-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: randomized trial comparing the fork-tip and the side-fenestrated needles for eus-guided fine-needle biopsy of solid pancreatic lesions, gastrointestinal endoscopy (2020).Source: article: crinò sf, le grazie m, manfrin e, conti bellocchi mc, bernardoni l, granato a, locatelli f, parisi a, di stefano s, frulloni l, larghi a, gabbrielli a, (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed between (b)(6) 2018 and (b)(6) 2019, one patient had intra-procedural peritoneal bleeding with a 4 g/dl hemoglobin level drop after the eus-fnb (endoscopic ultrasound fine-needle biopsy procedure).The patient was a renal cancer sampled metastasis sampled with a 25-gauge fork-tip needle.The patient was hospitalized but no blood transfusions were required.

• 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: 10264918
• Report Number: 3004904811-2020-00020
• Device Sequence Number: 2951558
• Product Code: FCG
• UDI-Device Identifier: 00855208005094
• UDI-Public: 00855208005094
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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-25-01
• Device Catalogue Number: DSC-25-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/13/2020
• 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: Hospitalization; Required Intervention