MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

Catalog Number ECHO-HD-22-EBUS-O

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687); Cough (4457)

Event Date 03/10/2022

Event Type  Injury  

Event Description

As reported by the initial reporter: "the physician retracted the scope and noticed the needle had broken-off.The physician went back-in and could not find the broken piece.The patient actually coughed-out the broken portion of the needle (while the patient was in the recovery area - after extubation / pulling the air way out)".Note: removal of the needle through the scope met resistance.

Manufacturer Narrative

Fcg kit, needle, biopsy.

Event Description

According to the mdr received from the uf: "patient was having an ebus procedure done in the operating room under general anesthesia.Intubated.Several passes had been done on the same lymph node using the ebus needle.With the last pass using this needle.Removal of the needle through the scope met much resistance.Assisting rt withdrew the needle and upon examination it appeared that part of the needle had broken off.Physician used the bronchoscope to examine all areas that are visible using the scope and no needle was observed.Procedure was continued using another needle and other instruments including fluoroscopy.Physician had the tech do a full fluoro scan of the lungs and no needle was observed.Here was no bleeding upon completion of the procedure.After extubation and while in recovery, the patient was coughing up blood tinged sputum.Pacu rn noted a metal object on his lip.Pulmonologist and anesthesia aware.Repeat cxr completed- no needle noted.Fair level of confidence that remainder of needle was coughed out.Fda safety report id# (b)(4).".

Manufacturer Narrative

D2) fcg.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 14117485
• MDR Text Key: 289322445
• Report Number: 3005580113-2022-00045
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002520117
• UDI-Public: (01)10827002520117(17)241202(10)C1892766
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2022,05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1892766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/27/2022
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2022
• Date Device Manufactured: 12/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 101 KG