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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY

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COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY Back to Search Results
Catalog Number ECHO-25
Device Problem Off-Label Use (1494)
Patient Problems Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
Event Type  malfunction  
Event Description
Garcia-sumalla et al 2020 ¿endoscopic ultrasound-guided transvascular needle biopsy of thoracic and abdominal lesions: a multicenter experience¿. ¿the primary aim of this multicenter study was to analyze the diagnostic yield and safety of eus-tv-fna in thoracic and abdominal lesions. Secondary aims were to assess the clinical impact and technical aspects of the procedure. ¿ prior to transvascular puncture, technical attempts were made to avoid an intravascular route. The target was identified, and the needle was advanced, traversing the vessel until the tip was seen inside the lesion, and then the stylet was removed. The suction technique applied, if any (stylet slow-pull vs. Standard suction), was applied, and needle type and size were selected at the discretion of the endosonographer (25 or 22g; echo- tip ultra-hd, cook or expect slimline, boston scientific). A total of 49 cases and 50 eus-tv-fna were collected, with a mean age of 64 years (sd 10. 6); more than half were men (54%). Technical aspects of fna: needle size, 22 and 25g (52% and 48% respectively), aspiration technique, suction-syringe and slow-pull (44% and 58% respectively); median number of passes was two (interquartile range: 1. 0 to 8. 0). Two minor mural hematomas (aorta and pulmonary artery) were detected on eus images immediately after a transvascular fna. Two hematomas after transaortic eus-fna using a 25-g needle (2 passes). This file is capturing off label use as the device was used in the transvascular route. Slow pull technique is also considered user error. No interventional procedures were required to manage these incidents.
 
Manufacturer Narrative
(b)(4). The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
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Brand NameECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Type of DeviceFCG KIT, NEEDLE, BIOPSY
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer (Section G)
COOK IRELAND LTD
o halloran road
national technology park
limerick
Manufacturer Contact
aisling hassett
o halloran road
national technology park
limerick 
MDR Report Key11516966
MDR Text Key280456074
Report Number3001845648-2021-00204
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K083330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberECHO-25
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/27/2020
Event Location Hospital
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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