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

Model Number	DSC-22-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pancreatitis (4481)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: dsc-22-01, dsc-22-01 sharkcore bio sys 22g ss ndl (lot#unknown).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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that after fine needle biopsy (fnb) and fine needle aspiration (fna) procedure, a patient had a complication of pancreatitis and severe bleeding which led to extended hospitalization.
Additional Manufacturer Narrative
Additional information: a2 (age at event), a3a, b3, b5, d1, d4 (model number, catalog number and udi), g3, pma / 510(k) # correction: b1 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 after fine needle biopsy (fnb), a patient had self limited intraluminal bleed.Patient had two eus-fnb procedures, 22g 3 passes on (b)(6)2024 and 22g 1 pass low-pull on (b)(6)2024.In both procedures, prolonged self-limiting intraluminal bleeding, reported as lasting more than usual but no hemostatic procedure carried out.No comorbidities and no concomitant treatments.Final diagnosis solid 2cm pancreatic tail mass, final diagnostic at second fnb of adenocarcinoma poorly differentiated.

• 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: 21137826
• Report Number: 3004904811-2025-00006
• Device Sequence Number: 17848825
• 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: Other Health Care 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DSC-22-01
• Device Catalogue Number: DSC-22-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 01/13/2025
• Supplement Report FDA Received Date: 02/13/2025
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female