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

Model Number G52011

Device Problems Kinked (1339); Retraction Problem (1536); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k160229.(b)(4).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

¿we used an ebus needle this morning which bent during the procedure and we were unable to pull it back through the scope so pulled the whole scope out with needle bent, through the mouth.When we looked at the needle it was very weak at the point where it bent (2cm from tip) and i think if we'd tried harder to pull it out it would have snapped in the trachea.We have saved the needle, would you like us to send it back?¿.

Manufacturer Narrative

Pma/510(k) # 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).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

¿we used an ebus needle this morning which bent during the procedure and we were unable to pull it back through the scope so pulled the whole scope out with needle bent, through the mouth.When we looked at the needle it was very weak at the point where it bent (2cm from tip) and i think if we'd tried harder to pull it out it would have snapped in the trachea.We have saved the needle, would you like us to send it back?¿ "as per complaint form": we used an ebus needle this morning which bent during the procedure and we were unable to pull it back through the scope so pulled the whole scope out with needle bent, through the mouth.When we looked at the needle it was very weak at the point where it bent (2cm from tip) and i think if we'd tried harder to pull it out it would have snapped in the trachea.

Event Description

¿we used an ebus needle this morning which bent during the procedure and we were unable to pull it back through the scope so pulled the whole scope out with needle bent, through the mouth.When we looked at the needle it was very weak at the point where it bent (2cm from tip) and i think if we'd tried harder to pull it out it would have snapped in the trachea.We have saved the needle, would you like us to send it back?¿ "as per complaint form": we used an ebus needle this morning which bent during the procedure and we were unable to pull it back through the scope so pulled the whole scope out with needle bent, through the mouth.When we looked at the needle it was very weak at the point where it bent (2cm from tip) and i think if we'd tried harder to pull it out it would have snapped in the trachea.1st pass sample acquired using needle.Quite difficult to get needle through tracheal wall.2nd pass needle did not easily pass through tracheal wall and i instructed spr who was holding the scope to gently advance the scope into the patient to apply additional pressure.Still unable to get needle into node therefore attempted to withdraw needle from tracheal wall, clear that it was bent to approx 80 degrees at approx 1.5cm from the tip.I decided to pull the whole scope with the needle protruding out through the patient's airway and mouth.Once scope out i bent the needle back straight to withdraw the needle from the scope and in doing this the needle snapped at the point of the bend.Sharp disposed of but the rest of the needle returned to cook.

Manufacturer Narrative

510(k) number: k160229.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: (b)(4).Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Device evaluation: the echo-hd-22-ebus-o device of lot number c1466152 involved in this complaint was returned for evaluation.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 or patient end)? patient end 2.Please describe the location in the body for the intended target site (pancreas, stomach, etc).Paratracheal lymph node (4r) 3.Please describe the size of the intended target site.1.5cm max diameter 4.If not with the device in question, how was the procedure performed and/or finished? with a new needle of same type 5.What is the endoscope manufacturer and model number that was used with this device? olympus ebus scope ¿ model number: 1110344.6.Was difficulty experienced while retracting the needle? yes 7.Was the needle able to be fully retracted before removing from the patient? no 8.Was gaining access to the targeted site difficult? yes 9.Was the endoscope in a flexed or twisted position at any time during the procedure? yes - flexed 10.Was needle penetration of the targeted site difficult? yes - difficult passing needle through tracheal wall 11.Was the stylet in place inside the needle when advancing into the targeted site? yes 12.How many biopsies were obtained with use of this needle? 1 13.Did any section of the device detach inside the patient? no the device related to this occurrence underwent a laboratory evaluation on the 25 july 2018.Needle tip of device broken.Kink noted at distal end of needle, possibly due to excessive force or device handling.Additionally this kink could have occurred during re-packaging for transport returns.97.8 cm of needle was returned.Location of kink, 27 cm from the broken distal end ( specification for needle 99.5cm +2mm/-2mm,).Location of kink, 27 cm from the broken distal end.Stylet and needle tip of device were missing components.Needle advances and retracts with slight resistance, due to kink.Following the laboratory evaluation, additional information was requested and received as follows: " needle tip of device was missing, therefore can you please confirm the location of needle tip? i'm afraid we disposed of it in the sharps bin.Was the stylet fully in place inside the needle when advancing into the targeted site? yes, we always leave the stylet fully in place" 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 torturous anatomy also due the device being used in a flexed position, depending on what lymph node was being targeted, as noted in additional information received.Additionally another possible root cause could be a trachea ring was hit during the procedure.Thereafter causing the needle breakage at the point of the bend.Prior to distribution, all echo-hd-22-ebus-o 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.A review of the manufacturing records for echo-hd-22-ebus-o device of lot# c1466152 did not reveal any discrepancies that could have contributed to this complaint issue.It may be noted that according to the instructions for use, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any 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.The customer complaint is confirmed as the failure was verified in the laboratory.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.

• 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: 7657612
• MDR Text Key: 112996177
• Report Number: 3001845648-2018-00308
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002520110
• UDI-Public: (01)00827002520110(17)210321(10)C1466152
• 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,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Model Number: G52011
• Device Catalogue Number: ECHO-HD-22-EBUS-O
• Device Lot Number: C1466152
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/27/2018
• Event Location: Hospital
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 140