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

Model Number G53408

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

The 510(k) number: k160229.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations, "they advanced the needle inside of sheath, through the scope, and got one pass for cytology.Pulled it out and went to make another pass but needle was not going into tissue.They pulled the it out and advanced outside of scope but there was no needle.Needle was sitting inside tissue of lungs.They were able to suction needle and take it out without complications.Finished the procedure with a wang aspiration needle successfully.".

Manufacturer Narrative

510(k) number: k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to mfr site as follows: importer site contact and address: (b)(6).(b)(4).Device evaluation: two echo-hd-22-ebus-p devices of lot number: c1508542 involved in this complaint were returned for evaluation.Device one was returned unused, the packaging was sealed on receipt.Device two, only broken part of the needle was returned.With the information provided, a physical examination and document based investigation was conducted.Additional information was received as follows 1.1.1 if the report involves a kink or bend in the needle, where is this located on the device (handle end or patient end)? no.1.1.2 please describe the location in the body for the intended target site (pancreas, stomach, etc).Inside the lungs.1.1.3 please describe the size of the intended target site.Unknown.1.1.4 what is the endoscope manufacturer and model number that was used with this device? pentax brachial ebus scope.1.1.5 was gaining access to the targeted site difficult? no.1.1.6 was the endoscope in a flexed or twisted position at any time during the procedure? no.1.1.7 was needle penetration of the targeted site difficult? no.1.1.8 was the stylet in place inside the needle when advancing into the targeted site? yes.1.1.9 how many biopsies were obtained with use of this needle? one.1.1.10 did any section of the device detach inside the patient? yes.1.1.11 was the needle fully retracted when the device was removed from the patient? yes.1.1.12 if not, with the device in question, how was the procedure performed and/or finished? wang aspiration needle.The device related to this occurrence underwent a laboratory evaluation on the 10th october 2018.Device one was returned unused, the packaging was sealed on receipt.Device two, only broken part of the needle was returned.Distal break of needle noted.Needle returned at 13 mm in length (specification for needle 745mm +1mm/-1mm).The customer complaint for used device is confirmed as the failure was verified in the laboratory, only broken part of the needle was returned.The customer complaint for unused device is not confirmed, as the failure was not verified in the laboratory.Device was returned unused and the packaging was sealed on receipt.Root cause: a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.However possible causes may be due to hard lesion.Additionally another possible root cause could be a trachea ring was hit during the procedure causing needle breakage.Document review: a review of qc lot: 316020 and qc#: 315962 determined that this item is supplied by creganna and is subject to incoming inspection as per iqc0499 and has been accepted in cirl.Prior to distribution, all echo-hd-22-ebus-p devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is no evidence to suggest that this issue affects the entire lot#: c1508542 upon review of complaints this failure mode has not occurred previously with this lot#: c1508542.A review of the manufacturing records for echo-hd-22-ebus-p device of lot#: c1508542 did not reveal any discrepancies that could have contributed to this complaint issue.Ifu review: the notes section of the instructions for use ifu0060-3 that accompanies this device instructs the user to inspect the device prior to use for any damage: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".On review of the information provided, there is no viable evidence to suggest that the user did not follow the instructions for use.There is no evidence to suggest that the customer did not follow the instructions for use ( ifu0060-3).Summary: the customer complaint for used device is confirmed as the failure was verified in the laboratory, only broken part of the needle was returned.The customer complaint for unused device is not confirmed, as the failure was not verified in the laboratory.Device was returned unused and the packaging was sealed on receipt.According to the initial reporter, 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 Description

As reported to customer relations, "they advanced the needle inside of sheath, through the scope, and got one pass for cytology.Pulled it out and went to make another pass but needle was not going into tissue.They pulled the it out and advanced outside of scope but there was no needle.Needle was sitting inside tissue of lungs.They were able to suction needle and take it out without complications.Finished the procedure with a wang aspiration needle successfully.".

• Brand Name: ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7893067
• MDR Text Key: 120830212
• Report Number: 3001845648-2018-00440
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002534087
• UDI-Public: (01)00827002534087(17)210608(10)C1508542
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Model Number: G53408
• Device Catalogue Number: ECHO-HD-22-EBUS-P
• Device Lot Number: C1508542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/24/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 08/24/2018
• Supplement Dates FDA Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention