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

Catalog Number ECHO-25

Device Problem Off-Label Use (1494)

Patient Problems Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Event Description

Garcia-sumalla et al 2020 ¿endoscopic ultrasound-guided transvascular needle biopsy of thoracic and abdominal lesions: a multicenter experience¿.¿the primary aim of this multicenter study was to analyze the diagnostic yield and safety of eus-tv-fna in thoracic and abdominal lesions.Secondary aims were to assess the clinical impact and technical aspects of the procedure.¿ prior to transvascular puncture, technical attempts were made to avoid an intravascular route.The target was identified, and the needle was advanced, traversing the vessel until the tip was seen inside the lesion, and then the stylet was removed.The suction technique applied, if any (stylet slow-pull vs.Standard suction), was applied, and needle type and size were selected at the discretion of the endosonographer (25 or 22g; echo- tip ultra-hd, cook or expect slimline, boston scientific).A total of 49 cases and 50 eus-tv-fna were collected, with a mean age of 64 years (sd 10.6); more than half were men (54%).Technical aspects of fna: needle size, 22 and 25g (52% and 48% respectively), aspiration technique, suction-syringe and slow-pull (44% and 58% respectively); median number of passes was two (interquartile range: 1.0 to 8.0).Two minor mural hematomas (aorta and pulmonary artery) were detected on eus images immediately after a transvascular fna.Two hematomas after transaortic eus-fna using a 25-g needle (2 passes).This file is capturing off label use as the device was used in the transvascular route.Slow pull technique is also considered user error.No interventional procedures were required to manage these incidents.

Manufacturer Narrative

(b)(4).The 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.

Manufacturer Narrative

Device evaluation the echo-25 devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article "garcia-sumalla 2020¿.Lab evaluation ¿ n/a.Documents review including ifu review: prior to distribution, all echo-25 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 numbers are unknown a review of manufacturing records could not be performed.The notes section of the instructions for use, ifu0101-1 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".Also, ¿intended use: this device is used to sample targeted submuscosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.¿ there is evidence to suggest that the customer did not follow the instructions for use (ifu0101-1).Image review ¿ n/a.Root cause review a definitive root cause could be attributed to off label use as the echo-25 device is intended to sample targeted submucosal gastrointestinal lesions but the transvascular route was used to access the lesion.There was no device defect identified within the article.As per medical affairs ¿i would presume it was off-label use.Transvascular route is still high risk and i don¿t think our engineers have tested that scenario." also, as per medical affairs ¿from medical affairs perspective, ma do not recommend it is on-label use via transvascular route especially aorta sine the risks associated with major vessels haven¿t been considered in risk system (e.G., pha, d/pfmea, rba or cer).¿ two minor mural hematomas (aorta and pulmonary artery) were detected on eus images immediately after a transvascular fna.The hematomas are captured under this file because based on clinical input the hematomas would not have required intervention to prevent permanent impairment or damage.The slow pull technique was used by the doctor, although, this is a technique and not considered off label/user error.It should be noted that the ifu is being considered for update to consider this technique.Clarification was received as follows: the slow pull technique is not considered off label use.The echotip ultra and echotip procore gi ifus (ifu0077 and ifu0101) will be updated as part of their mdr submissions to align with the wording already added to the ebus ifus: ¿standard vacuum syringe techniques may be applied¿or, if desired, other techniques that may or may not incorporate the use of the stylet may be used.¿ summary: complaint is confirmed based on customer testimony.According to the initial reporter, two minor mural hematomas (aorta and pulmonary artery) were detected on eus images immediately after a transvascular fna.Based on clinical input the hematomas would not have required intervention to prevent permanent impairment or damage.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Follow-up mrd being submitted per product management feedback recieved 03-jun-2021 confirming slow pull technique is not user error.Supplement report is required to capture the updated event description.Garcia-sumalla et al 2020 ¿endoscopic ultrasound-guided transvascular needle biopsy of thoracic and abdominal lesions: a multicenter experience¿ ¿the primary aim of this multicenter study was to analyze the diagnostic yield and safety of eus-tv-fna in thoracic and abdominal lesions.Secondary aims were to assess the clinical impact and technical aspects of the procedure.¿ prior to transvascular puncture, technical attempts were made to avoid an intravascular route.The target was identified, and the needle was advanced, traversing the vessel until the tip was seen inside the lesion, and then the stylet was removed.The suction technique applied, if any (stylet slow-pull vs.Standard suction), was applied, and needle type and size were selected at the discretion of the endosonographer (25 or 22g; echo- tip ultra-hd, cook or expect slimline, boston scientific).A total of 49 cases and 50 eus-tv-fna were collected, with a mean age of 64 years (sd 10.6); more than half were men (54%).Technical aspects of fna: needle size, 22 and 25g (52% and 48% respectively), aspiration technique, suction-syringe and slow-pull (44% and 58% respectively); median number of passes was two (interquartile range: 1.0 to 8.0).Two minor mural hematomas (aorta and pulmonary artery) were detected on eus images immediately after a transvascular fna.Two hematomas after transaortic eus-fna using a 25-g needle (2 passes).This file is capturing off label use as the device was used in the transvascular route.No interventional procedures were required to manage these incidents.

Manufacturer Narrative

Device evaluation the echo-25 devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article "garcia-sumalla 2020¿ lab evaluation ¿ n/a documents review including ifu review: prior to distribution, all echo-25 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 numbers are unknown a review of manufacturing records could not be performed.The notes section of the instructions for use, ifu0101-1 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".Also, ¿intended use: this device is used to sample targeted submuscosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.¿ there is evidence to suggest that the customer did not follow the instructions for use (ifu0101-1).Image review ¿ n/a root cause review a definitive root cause could be attributed to off label use as the echo-25 device is intended to sample targeted submucosal gastrointestinal lesions but the transvascular route was used to access the lesion.There was no device defect identified within the article.As per medical affairs ¿i would presume it was off-label use.Transvascular route is still high risk and i don¿t think our engineers have tested that scenario." also, as per medical affairs ¿from medical affairs perspective, ma do not recommend it is on-label use via transvascular route especially aorta sine the risks associated with major vessels haven¿t been considered in risk system (e.G., pha, d/pfmea, rba or cer).¿ two minor mural hematomas (aorta and pulmonary artery) were detected on eus images immediately after a transvascular fna.The hematomas are captured under this file because based on clinical input the hematomas would not have required intervention to prevent permanent impairment or damage.The slow pull technique was used by the doctor, although, this is a technique and not considered off label/user error.It should be noted that the ifu is being considered for update to consider this technique.Clarification was received as follows: the slow pull technique is not considered off label use.The echotip ultra and echotip procore gi ifus (ifu0077 and ifu0101) will be updated as part of their mdr submissions to align with the wording already added to the ebus ifus: ¿standard vacuum syringe techniques may be applied¿or, if desired, other techniques that may or may not incorporate the use of the stylet may be used.¿ summary: complaint is confirmed based on customer testimony.According to the initial reporter, two minor mural hematomas (aorta and pulmonary artery) were detected on eus images immediately after a transvascular fna.Based on clinical input the hematomas would not have required intervention to prevent permanent impairment or damage.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Annex e2403 code was removed on (b)(6) 2022, this follow up report is being submitted to include this change.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND 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: 11516966
• MDR Text Key: 280456074
• Report Number: 3001845648-2021-00204
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2022

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-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/27/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 02/18/2021; 02/18/2021; 02/18/2021
• Supplement Dates FDA Received: 07/01/2021; 09/23/2021; 03/21/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male