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

Catalog Number ECHO-HD-22-EBUS-O-C

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

As initially reported to customer relations via email: a patient of undisclosed gender and age underwent a lymph node biopsy in which the procore needle was used.We [the customer] had just performed a lymph node biopsy of station 7 and were moving on to station 4r.We [the customer] attempted 3 passes and were having difficulty entering the node.We [the customer] repositioned 3 times and on the third attempt, after we [the customer] tried to insert the needle into the node, we [the customer] were unable to pull back the needle.I [the customer] also tried pulling back the guidewire with no success.Ended up having to pull out the entire scope to find the needle bent at about a 45-degree angle.We [the customer] ended up having to push the needle out and cut off the tip in order to remove the needle from the scope.Luckily there was no harm done to the patient or the ebus scope.Did any unintended section of the device remain inside the patient¿s body? if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? rls internally has been completed.Has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.3.0 example of rpn prefix echo.3.1 for all complaints, ask: 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))? refer to image in attached email please describe the location in the body for the intended target site (pancreas, stomach, lungs, etc).If lungs, which lymph node was being targeted? e.G.2r, 2l, 4r, ao, ar, 11ri, 11s, etc.Please describe the size of the intended target site.If not with the device in question, how was the procedure performed and/or finished? was the device used in a tortuous position? are images of the device or procedure available? yes, see attached email.Was the device damaged in packaging before removal? was the device damaged on removal from packaging? was force required to remove the device? for complaints occurring during use (once in contact with endoscope), also ask: what is the endoscope manufacturer and model number that was used? was the scope recently service/repaired? was force required on insertion of device into scope? was resistance felt while inserting the device through the scope? when was the issue noted? e.G.On advancement of the sheath/needle or on needle retraction? was the syringe used during the procedure, after the stylet was removed? was difficulty experienced while retracting the needle? was it possible to be fully retract before removing the needle from the patient? was gaining access to the targeted site difficult? was the endoscope in a flexed or twisted position at any time during the procedure? was puncture of the targeted site difficult? was the stylet fully in place inside the needle when advancing into the targeted site? was the stylet partially removed when advancing into the target site? how many samples were obtained with this needle? did any section of the device detach inside the patient? if the device kinked below the sheath extender, was the kink observed before inserting the device into the scope? was there difficulty locking the sheath (or needle) in place or slipping experienced during use? was there difficulty in attaching or detaching of the device leur lock to the scope? if device is a procore needle, is the kink located distally at the notch /core trap? refer to image in attached email.

Manufacturer Narrative

Pma/510(k) # k160229.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 26-jan-2022.

Manufacturer Narrative

Pma/510(k) # k160229.Device evaluation 1 unit of unknown lot number of echo-hd-22-ebus-o-c was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation n/a.Document review including ifu review prior to distribution, all echo-hd-22-ebus-o-c 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.As the lot number is unknown a review of manufacturing records could not be performed.The notes section of the instructions for use, ifu0109-6 which accompanies this device instructs the user; "if excessive resistance is encountered on needle advancement, retract the needle into the sheath with the thumbscrew locked at the 0 cm mark, reposition the scope and attempt needle advancement from another angle.Failure to do so may result in needle breakage, device damage or malfunction.¿¿ there is no evidence to suggest that the customer did not follow the instructions for (ifu0109-6).Image review n/a root cause review a definitive root cause could not be determined from the available information.A possible root cause of the distal needle kink could be attributed to the needle tip coming into contact with a hard lesion as it is known the customer had difficulty puncturing the node.Another possible root cause which contributed to the needle damage that was advised by the customer is that they may have hitting the cartilage on the trachea.Summary complaint is confirmed based on images provided by the customer.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 trend.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 13226316
• MDR Text Key: 294033271
• Report Number: 3001845648-2022-00010
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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