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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BARRX SHARKCORE; BIOPSY NEEDLE
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COVIDIEN LP BARRX SHARKCORE; BIOPSY NEEDLE Back to Search Results
Model Number DSC-22-01
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Abdominal Pain (1685); Vomiting (2144); Pancreatitis (4481)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Title: ath-04 comparing the diagnostic yield and safety of endosonography guided use of shark-core and pro-core needles; 2019 source: 10.1136/gutjnl-2019-bsgabstracts.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to literature source of study performed, a total of 143 patients having 151 pancreatic lesions were analyzed.69 patients used shark-core while 74 patients used pro-core.74 lesions were biopsied in shark-core group from 69 patients.Four patients had their procedure repeated.2 patients developed mild pancreatitis and one required admission with epigastric pain and vomiting.
 
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Brand Name
SHARKCORE
Common Device Name
BIOPSY NEEDLE
Manufacturer (Section D)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
MDR Report Key12744450
Report Number3004904811-2021-00016
Device Sequence Number14572691
Product Code FCG
UDI-Device Identifier00855208005087
UDI-Public00855208005087
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K141894
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,l
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/03/2021
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 NumberDSC-22-01
Device Catalogue NumberDSC-22-01
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/13/2021
Initial Report FDA Received Date11/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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