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

Model Number G34279

Device Problems Break (1069); Retraction Problem (1536)

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

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Consultant (b)(6) advised the sheath cannot be advanced into the lock position.Reoccurring issue and said it's a "complete collapse" of their service due to damage of scopes.

Event Description

Consultant (b)(6) advised the sheath cannot be advanced into the lock position.Reoccurring issue and said it's a "complete collapse" of their service due to damage of scopes.Additional information received as follows: we have contradicting information regarding this complaint; we need to have complete and accurate information before we can conduct an investigation, please see below information received.*consultant managed to push it out and lock it in position in the end.*where the sheath cannot be advanced into the lock position and same thing happen today inside and outside the bronchial tree.This ~ was difficulty experienced while retracting the needle? no¿ was the needle able to be fully retracted before removing from the patient? no ~ a part of the needle did break off in the patient but was successfully retrieved in the same procedure.¿ if the needle was not fully retracted back into the device this would lead to scope damage, it stated in the ifu that the needle must be fully retracted before removing from the patient.>> couldn't be fully retracted as a piece came off inside the patient.The rest was fully retrieved.¿ did the dr have an issue locking the sheath adjuster into position? >> yes ¿ was the device pre-assessed before using i.E outside of the patient to ensure thumbscrews can be locked? >> yes ¿ if he/she experienced trouble with locking why did the procedure continue? >> because they managed to lock it in the end.¿ was the scope pre flushed/cleaned before the procedure to ensure damage was not caused from a prior patient? >> of course it was.It's a legal requirement.¿ can you tell me at what point during the procedure did the dr notice the break especially if it was not used to collect a sample? >> it was used to collect a sample.Unsure when it broke off.¿ was the device in the target position before trying to advance? >> yes ¿ did the dr see the sheath on the ultrasound before advancing to target site? >> yes.

Manufacturer Narrative

Pma/510(k) # k160229 (b)(4).Exemption number: e2016031 (b)(4) investigation is pending.A follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # k160229.(b)(4).Exemption number: e2016031.(b)(4).The device involved in this complaint was not available for return to cirl.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.Additional information received the 24th of jan: we have contradicting information regarding this complaint; we need to have complete and accurate information before we can conduct an investigation, please see below information received.*consultant managed to push it out and lock it in position in the end.*where the sheath cannot be advanced into the lock position and same thing happen today inside and outside the bronchial tree.This was difficulty experienced while retracting the needle? no¿ was the needle able to be fully retracted before removing from the patient? no a part of the needle did break off in the patient but was successfully retrieved in the same procedure.¿ if the needle was not fully retracted back into the device this would lead to scope damage, it stated in the ifu that the needle must be fully retracted before removing from the patient.>> couldn't be fully retracted as a piece came off inside the patient.The rest was fully retrieved.¿ did the dr have an issue locking the sheath adjuster into position? >> yes ¿ was the device pre-assessed before using i.E outside of the patient to ensure thumbscrews can be locked? >> yes ¿ if he/she experienced trouble with locking why did the procedure continue? >> because they managed to lock it in the end.¿ was the scope pre flushed/cleaned before the procedure to ensure damage was not caused from a prior patient? >> of course it was.It's a legal requirement.¿ can you tell me at what point during the procedure did the dr notice the break especially if it was not used to collect a sample? >> it was used to collect a sample.Unsure when it broke off.¿ was the device in the target position before trying to advance? >> yes ¿ did the dr see the sheath on the ultrasound before advancing to target site? >> yes root cause: it is difficult to determine a root cause without being able to inspect the device however this occurrence may be due to the sheath adjuster locking ring becoming jammed or not tightened to the desired length the needle may have become broken distally due to excessive force that may have been applied when trying to access the target site.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.The notes section of the instructions for use, ifu0109-5, advises the user ¿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 this issue effects the entire lot # c1400527 ; upon review of complaints this failure mode has not occurred previously with this lot # c1400527.A review of the manufacturing records for lot# c1400527 did not reveal any discrepancies which could have led to this occurrence.From the information provided, no adverse effects to the patient have been reported as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Report is being submitted based on the precedence for non retraction of the needle and a report of the needle breaking.Additional information received as follows: we have contradicting information regarding this complaint; we need to have complete and accurate information before we can conduct an investigation, please see below information received.*consultant managed to push it out and lock it in position in the end.*where the sheath cannot be advanced into the lock position and same thing happen today inside and outside the bronchial tree.This ~ was difficulty experienced while retracting the needle? no¿ was the needle able to be fully retracted before removing from the patient? no ~ a part of the needle did break off in the patient but was successfully retrieved in the same procedure.¿ if the needle was not fully retracted back into the device this would lead to scope damage, it stated in the ifu that the needle must be fully retracted before removing from the patient.>> couldn't be fully retracted as a piece came off inside the patient.The rest was fully retrieved.¿ did the dr have an issue locking the sheath adjuster into position? >> yes ¿ was the device pre-assessed before using i.E outside of the patient to ensure thumbscrews can be locked? >> yes ¿ if he/she experienced trouble with locking why did the procedure continue? >> because they managed to lock it in the end.¿ was the scope pre flushed/cleaned before the procedure to ensure damage was not caused from a prior patient? >> of course it was.It's a legal requirement.¿ can you tell me at what point during the procedure did the dr notice the break especially if it was not used to collect a sample? >> it was used to collect a sample.Unsure when it broke off.¿ was the device in the target position before trying to advance? >> yes ¿ did the dr see the sheath on the ultrasound before advancing to target site? >> yes.

• 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: 7163951
• MDR Text Key: 96965568
• Report Number: 3001845648-2018-00006
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798(17)200914(10)C1400527
• 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: 01/31/2018

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 Model Number: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 12/07/2017; 12/07/2017
• Supplement Dates FDA Received: 01/31/2018; 02/28/2018
• Patient Sequence Number: 1