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

Model Number DSC-25-01

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

Patient Problem No Code Available (3191)

Event Date 05/17/2020

Event Type  Injury  

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 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
• 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: 10264918
• MDR Text Key: 198598331
• Report Number: 3004904811-2020-00020
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00855208005094
• UDI-Public: 00855208005094
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K141894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DSC-25-01
• Device Catalogue Number: DSC-25-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• 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