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

Catalog Number ECHO-HD-22-EBUS-O

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Fcg kit, needle, biopsy.

Event Description

According to the initial reporter, during an ebus procedure, the needle that was being used broke off inside the patient¿s airway.It was the echo-hd 22-ebus-o.We weren't doing anything unusual for this to happen either.The node was pierced and we couldn see the needle on ultrasound so the physician put the stylet back in to try to wiggle it and see if they could see it, but the stylet wouldn't go in all the way, so the physician thought maybe the needle was bent and they decided to switch to a new needle.But when the physician tried to pull the needle back into the sheath and met some resistance and then felt it give and they it was pulled out.At that point they could see a portion of the needle still in the patient¿s airway.Further information provided needle was introduced easily and sheath was removed, but was not able to be seen in the ultrasound image.When the physician tried to reintroduce the sheath it would not go in completely.The physician then tried to retract the needle and met resistance, but the physician felt it give and was able to retract it.They switched needles then and upon entry and were able to view the remaining part of the previous needle which we then were able to remove using biopsy forceps.The patient did not require further care.

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11030479
• MDR Text Key: 222336756
• Report Number: 3005580113-2020-00464
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002520117
• UDI-Public: (01)10827002520117(17)230907(10)C1756800
• 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
• Type of Report: Initial
• Report Date: 12/16/2020,12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1756800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2020
• Date Device Manufactured: 09/07/2020
• 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 Age: 74 YR
• Patient Weight: 84