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

Model Number	DSC-22-01
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pancreatitis (4481)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that they had a case of severe bleeding and pancreatitis after a fine needle biopsy and fine needle aspiration procedures for cyst aspiration, cyst aspiration with solid components, and solid mass tissue sample, and one patient died as a result of the complication using fine needle aspiration needle.
Additional Manufacturer Narrative
Additional information: a2(age at event), a3a, a5a, a5b, b2, b3, b5, h3, h6 d10 concomitant product: dsn-22-01, dsn-22-01 bnx delivery sys 22g ss needle (lot#unknown); unk-beacon, unknown beacon (lot#unknown) additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a patient died after a fine needle aspiration procedure.Patient was admitted the day after beacon fna 22g 1 pass procedure cyst emptying due to fulminant acute pancreatitis.Patient died the following day after admitted, with multi-organ failure.Patient final diagnosis atypic simple cyst (cytohistologic and lab negative for cancer) of pancreas/mesentery.Immediate management for fulminant acute pancreatitis and comorbidity of hypertension (in target with treatment), mediterranean anemia trait (normal hgb levels), no concomitant treatments.

• Brand Name: SHARKCORE
• Common Device Name: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21152967
• Report Number: 3004904811-2025-00011
• Device Sequence Number: 21164616
• Product Code: FCG
• UDI-Device Identifier: 00855208005087
• UDI-Public: 00855208005087
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2026
• Device Model Number: DSC-22-01
• Device Catalogue Number: DSC-22-01
• Device Lot Number: B000003228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/13/2025
• Date Device Manufactured: 08/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male