MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number	ECHO-HD-19-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device, echo-hd-19-a of lot# c1200430 has been delivered and is awaiting lab evaluation.Please note that the echotip® ultra hd ultrasound access needle has a atraumatic (blunt) needle tip designed to allow passage of a.035¿ wire guide to maintain access and has a beveled stylet used to puncture and gain access.The device has been returned and is pending lab evaluation.The customer complaint is considered confirmed based on customer testimony.The instructions for use, (b)(4), advises the user to ¿visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use¿.A review of the manufacturing records for echo-hd-19-a devices of lot number c1200430 did not reveal any discrepancies which could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1200430; upon review of complaints this failure mode has not occurred previously with this lot # c1200430.The patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
After failing to drain the targeted cyst using the eus linear endoscope and the echo product, the physician took out the product and found that the sheath and the needle were disconnected.No component remained in the patient's body and the procedure was successful using a new echo product.
Additional Manufacturer Narrative
Additional information: ¿after failing to drain the targeted cyst using the eus linear endoscope and the echo product, the physician took out the product and found that the sheath and the needle were disconnected.No component was remained in the patient's body and the procedure went successful using a new echo product.¿ the complaint is related to 1 x echo-hd-19-a device of lot number c1200430.The device was returned with the needle broken and stylet removed.The device was examined and a kink was visible below the sheath extender when the sheath extender was positioned at reference mark 0.On further inspection several bends were noted on the outer sheath at 20cm, 34.5cm and 46cm from the distal end of the handle.During the evaluation a bend at 42cm and a wave at 14cm from the needle tip were both noted on the needle.A bend in the sheath was also noted at 31cm from the distal tip of the needle and the needle cannula was noted to be broken at 45cm from the needle tip.The needle was examined under microscope and evidence of kinking on the needle was observed at the break of the cannula.The customer complaint was confirmed as the needle cannula was broken.A possible cause of this complaint may be due to mishandling of the product during the procedure.It is possible for the needle to be damaged due to product handling when advancing/removing the device from the endoscope, or during expelling the biopsy specimens on the slide.As the conditions of device usage could not be replicated during the laboratory evaluation a cause for the needle kinking within the handle could not be determined.Please note that the echotip® ultra hd ultrasound access needle has a atraumatic (blunt) needle tip designed to allow passage of a.035¿ wire guide to maintain access and has a beveled stylet used to puncture and gain access.The customer complaint was confirmed as the needle cannula was broken.The instructions for use, advises the user to ¿visually inspect with particular attention to kinks, bends or breaks.If an abnormality is detected that would prohibit proper working condition, do not use¿.A review of the manufacturing records for echo-hd-19-a devices of lot number c1200430 did not reveal any discrepancies which could have contributed to this complaint issue.The patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This is a follow up report due to the completion of the investigation.After failing to drain the targeted cyst using the eus linear endoscope and the echo product, the physician took out the product and found that the sheath and the needle were disconnected.No component remained in the patient's body and the procedure was successful using a new echo product.

• Brand Name: ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 5808320
• Report Number: 3001845648-2016-00186
• Device Sequence Number: 724402
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)190209(10)C1200430
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K092359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ECHO-HD-19-A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/22/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2016
• Supplement Report FDA Received Date: 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1