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

Model Number	DSN-22-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sedation (2368)
Date of Event	12/23/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: randomized non-inferiority trial comparing diagnostic yield of cytopathologist-guided versus seven passes for endoscopic ultr asound-guided fine-needle aspiration of pancreatic masses source: digestive endoscopy 2016; 28: 469¿475; linda s.Lee, division of gastroenterology, received 27 october 2015; accepted 16 december 2015.If information is provided in the future, a supplemental report will be issued.[(b)(4)].
Event or Problem Description
According to the reporter, this was study regarding a comparison between 2 methods of using the aspiration needle.There were findings of complications on both methods.Post study revealed that there were 5 complications in the cytopathologist -guided arm which included three acute pancreatitis wherein one patient had undergone an endoscopic retrograde cholangio-pancreatography at the same time obtaining adequate aspirate of solid mass (pancreatic) using eus.There was one patient that fell during the recovery period, but without associated injuries.The last patient had a broken needle requiring removal of the echoendoscope.Based from the seven-passes there were three complications which included to one patient experiencing an intraprocedure bradycardia that was responded with atropine.Another patient experienced a respiratory distress leading to the procedure being aborted.The last patient developed abdominal pain and fever (normal laboratory studies and abdominal computed tomography) that eventually resolved spontaneously.

• Brand Name: BNX
• Common Device Name: KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 8701877
• Report Number: 3004904811-2019-00023
• Device Sequence Number: 1924848
• Product Code: FCG
• UDI-Device Identifier: 00855208005018
• UDI-Public: 00855208005018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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: DSN-22-01
• Device Catalogue Number: DSN-22-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/14/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 72