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

Model Number G34279

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

During the procedure the needle broke and remain inside the patient.A specific procedure has been done to remove it without consequence to the patient."as per complaint form": during procedure when the needle entered the lesion it broken it self.

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 section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Device evaluation: the echo-hd-22-ebus-p-c device of lot number c1457000 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Additional information was received as follows: 1.If the report involves a kink or bend in the needle, where is this located on the device (handle end (proximal end) or patient end (distal end))? patient end 2.Please describe the location in the body for the intended target site (pancreas, stomach, lungs etc.).Trachea and lungh.A.If the lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s etc.4r 3.Please describe the size of the intended target site.2 cm 4.If not with the device in question, how was the procedure performed and/or finished? the procedure was stopped and the tip of the needle was removed from the trachea wall with forceps.5.Was the device used in a tortuous position? no 6.Are images of the device or procedure available? no 7.Was it damaged in packaging before removal? no 8.Was it damaged on removal from packaging? no 9.Was force required to remove the device? no 10.What is the endoscope manufacturer and model number that was used? pentax scope 11.Was the scope recently serviced / repaired? yes a few months ago 12.Was force required on insertion of device into scope? no 13.When was the issued noted? e.G.On advancement of the sheath/needle or on needle retraction? on advancement of the needle.14.What is the endoscope manufacturer and model number that was used with this device? pentax scope 15.Was difficulty experienced while retracting the needle?not easy 16.Was the needle able to be fully retracted before removing from the patient? no 17.Was gaining access to the targeted site difficult? yes 18.Was the endoscope in a flexed or twisted position at any time during the procedure? no 19.Was needle penetration of the targeted site difficult? yes 20.Was the stylet fully in place inside the needle when advancing into the targeted site? yes 21.Was the stylet partially removed prior to advancement of needle? no 22.How many biopsies/passes were obtained with use of this needle? none 23.Did any section of the device detach inside the patient? tip of the needle 24.If kinked below the sheath extender, did they notice the kink before placing the device into the scope? no 25.Was there difficulty or slipping experienced of the sheath extender or lock ring during use? no 26.Was there difficulty in attachment / detachment of the leur to the scope? no 27.If the device is procore and it is kinked distally, is the kink at the notch / core trap? the device related to this occurrence underwent a laboratory evaluation on the 15 august 2018.Needle tip broken 15 mm distally (specification 45 mm +3mm/-3mm, ref.¿dwg1206¿).Stylet will not advance beyond kink.Visual inspection was carried out.The customer complaint is considered to be confirmed as the failure was verified in the laboratory.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 it is possible that the needle tip breakage occurred due to penetration of target side being difficult, as noted in additional information received.Additionally a possible root cause may have been that the needle became broken by a hard node or possibly by hitting a tracheal ring.Document review: a review of the manufacturing records forecho-hd-22-ebus-p-c of lot number c1457000 did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot #c1457000 upon review of complaints this failure mode has not occurred previously with this lot # c1457000.Ifu review the notes section of the instructions for use, ifu0110-5, which accompanies this device instructs the user to: "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0110-5).Summary: the customer complaint is considered to be confirmed as the failure was verified in the laboratory.The risk associated with this complaint is risk category iib/moderate risk level.According to the initial reporter, patient did not require any additional procedures due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

During the procedure the needle broke and remain inside the patient.A specific procedure has been done to remove it without consequence to the patient."as per complaint form": during procedure when the needle entered the lesion it broken it self.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7784596
• MDR Text Key: 117144433
• Report Number: 3001845648-2018-00381
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798(17)210222(10)C1457000
• 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: 08/15/2018

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: 02/22/2021
• Device Model Number: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C1457000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention