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

Catalog Number ECHO-HD-22-EBUS-P

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Mdr is being submitted based on the malfunction precedence of 'non-retraction of needle'.The ebus needle distal side become bent and almost broke during the procedure.The needle was replaced by other one.

Manufacturer Narrative

Pma/510(k) # k160229.(b)(4).The customers¿ complaint issue was reported as follows: ¿the ebus needle distal side become bent and almost broke during the procedure.The needle was replaced by other one.¿ additional information was received "regarding needle retraction-as much as i know and understood from the doctor, the needle was retracted to the sheath before removal." r and d provided a possible root cause: the root cause for this complaint is more than likely the physician tried to advance the needle into the tracheal rings causing the needle to bend.A caution note is in the product ifu stating the following ¿if excessive resistance is encountered on needle advancement, retract the needle into the sheath with the thumbscrew locked at 0 cm mark, reposition the scope and attempt needle advancement from another angle.Failure to do so may result in device damage or malfunction¿.The device involved in this complaint was not available for return to cook ireland for evaluation.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.Echo-hd-22-ebus-p devices of lot number c1192811 included the component irs0095 22ga ebus needle sub assembly of lot# ch1182719.Prior to distribution, all echo-hd-22-ebus-p devices are subjected to functional checks and visual inspection to ensure integrity of the product.These inspections and functional checks are outlined in internal procedures in place at (b)(4).A review of the manufacturing records for echo devices of lot# c1192811 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 # c1192811; upon review of complaints this failure mode has not occurred previously with this lot # c1192811 the notes section of the instructions for use ifu0060-2 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".From the information provided to us 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

This follow up mdr is being submitted to include investigation conclusions.Additional information was received from the customer confirming that the needle could be fully retracted.However, from the image provided, it is very unlikely that this needle could be retracted into the sheath without perforating the sheath.Clarification has been sent out and still awaiting confirmation.Adopting a cautious approach an fda mdr report is still required based on the assumption that 'sheath perforation' occurred when needle was being retracted.The ebus needle distal side become bent and almost broke during the procedure.The needle was replaced by other one.

Manufacturer Narrative

Pma/510(k) # k160229 (b)(4).The customers¿ complaint issue was reported as follows: ¿the ebus needle distal side become bent and almost broke during the procedure.The needle was replaced by other one.¿ additional information was received "regarding needle retraction-as much as i know and understood from the doctor, the needle was retracted to the sheath before removal." r&d provided a possible root cause: "the root cause for this complaint is more than likely the physician tried to advance the needle into the tracheal rings causing the needle to bend.A bend like this could lead to retraction difficulties rather than sheath perforation / damage.The needle possibly could have been retracted with such a bend.It the customer stated there was no issue with retraction then we have to believe what they say right? they might have not thought it be difficult to retract whereas some other physician might disagree but i think it would be possible to retract the needle." engineering have provided additional feedback: "due to this device not being returned it is impossible to say if the user could retract it without perforating the sheath.Maybe it could be retracted without perforating the sheath but we can't say for certain.It could be possible." a caution note is in the product ifu stating the following ¿if excessive resistance is encountered on needle advancement, retract the needle into the sheath with the thumbscrew locked at 0cm mark, reposition the scope and attempt needle advancement from another angle.Failure to do so may result in device damage or malfunction¿.The device involved in this complaint was not available for return to cook ireland for evaluation.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.Prior to distribution, all echo-hd-22-ebus-p devices are subjected to functional checks and visual inspection to ensure integrity of the product.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 # c1192811; upon review of complaints this failure mode has not occurred previously with this lot # c1192811.The notes section of the instructions for use ifu0060-2 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".From the information provided to us 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

This follow up mdr is being submitted due to additional information received.Additional information was received from the customer confirming that there was no sheath perforation.Engineering have provided their feedback: "due to this device not being returned it is impossible to say if the user could retract it without perforating the sheath.Maybe it could be retracted without perforating the sheath but we can't say for certain.It could be possible." additional information was received from the customer on the (b)(6) 2017 contradicting the information the customer provided on the (b)(6) 2017 and the (b)(6) 2017.Adopting a cautious approach an fda mdr report is still required based on the assumption that 'sheath perforation' could still potentially occur due to the severe bend of the needle and that the customer's information is contradictory.The ebus needle distal side become bent and almost broke during the procedure.The needle was replaced by other one.

• 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
• Manufacturer Contact: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6536373
• MDR Text Key: 74177729
• Report Number: 3001845648-2017-00158
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002534087
• UDI-Public: (01)00827002534087(17)190120(10)C1192811
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• 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-P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/02/2017
• Event Location: Hospital
• Date Manufacturer Received: 05/31/2017
• Date Device Manufactured: 01/20/2016
• 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