MAUDE Adverse Event Report: COOK ENDOSCOPY ECHOTIP ULTRA FIDUCIAL NEEDLE; NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT

Model Number G03793

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluations: device one (1): our laboratory evaluation of the product said to be involved determined the needle had a significant bend.The stylet wire and two fiducials that had not been deployed were included in the return.The stylet wire was returned extending 1.2 cm outside the proximal end of the handle.The stylet wire exhibited a bend near the area that was outside of the proximal end of the handle.The needle adjuster was placed on "8" and the needle advanced and retracted as expected when the handle was manipulated.The handle was manipulated forward in the advanced position and a visual inspection of the needle was performed.The needle exhibited a significant bend distal to the sheath.The needle was bent from the distal tip of the sheath to the distal tip of the bevel of the needle.During a functional test the device was placed down an olympus gf uc160p (3.2 mm channel endoscope) and the endoscope was placed in a curved position.The needle advanced and retracted when the handle was manipulated as intended.The thumb ring was bent back to straighten the stylet wire.When pressure was applied to the thumb ring, the thumb ring bent again.Deployment of the fiducials was unsuccessful.The device was taken out of the (endoscopic ultrasonography) eus endoscope and the stylet was replaced with a stylet wire from our lab stock.The device was advanced back through the endoscope and the needle was extended outside the distal end of the sheath.Both fiducials deployed with success.A dimensional verification under magnification was performed on the needle, the slot the fiducials were placed in and the fiducials.The length of the fiducial slot was within the specification.The width of small slot that opens up when the fiducials was deployed was within specification.The large slot which the fiducials rest in prior to deployment was within the specification.The length from the first dimple to the distal tip of the bevel was also within specification.The two (2) fiducials were measured.Both fiducials were within specification for the length.Both fiducials also met the specification for the tab length.The overall height of the fiducials were within specification.The tab width of both were within the specification.Device two (2): our laboratory evaluation of the product said to be involved determined the needle had a significant bend.The stylet wire and three (3) fiducials that had not been deployed were included in the return.The stylet wire was returned extended 2.9 cm outside the proximal end of the handle.The stylet wire exhibited a bend near the area that was outside of the proximal end of the handle.The needle adjuster was placed on "8" and the needle advanced and retracted as expected when the handle was manipulated.The handle was manipulated forward in the advanced position and a visual inspection of the needle was performed.The needle exhibited a significant bend distal to the sheath.The needle was bent from the distal tip of the sheath to the distal tip of the bevel of the needle.A bend in the sheath was observed at 2.9 cm from the base of the handle.The sheath being bent in this area can occur if the handle of the device is not attached to the biopsy port.In addition, a bend in the sheath and the needle in this area, can contribute to deployment difficulty.A second bend in the sheath was found at 87.4 cm from the base of the handle.During a functional test the device was placed down an olympus gf uc160p (3.2 mm channel endoscope) and the endoscope was placed in a curved position.The needle advanced and retracted when the handle was manipulated as intended.The thumb ring was bent back to straighten the stylet wire.Pressure was then applied to the thumb ring to test deployment of the fiducials; deployment was successful.A dimensional verification under magnification was performed on the needle, the slot the fiducials were placed in and the fiducials.The length of the fiducial slot was within the specification, however the bend in the device made it difficult to get an accurate measurement.The width of small slot that opens up when the fiducials had deployed was within specification.The large slot which the fiducials rest in prior to deployment was within the specification.The length from the first dimple to the distal tip of the bevel was also within specification.The three (3) fiducials were measured.All three (3) fiducials were within specification for the length.The fiducials also met the specification for the tab length.The overall height of the fiducials were within specification.The tab width of the three (3) fiducials were within the specification.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation evaluation: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use states: "identify desired site based on previous findings from endoscopy, radiography and/or ct scans.Slowly introduce needle into accessory channel of endoscope and advance in short increments.Ensure needle is completely retracted and locked in place.Note: bends or kinks in needle caused by improper introduction may result in the inability to deploy fiducials." the instruction for use states: "attach device to endoscope accessory channel port." the instructions for use cautions the user: "failure to attach device prior to needle adjustment or extension may result in damage to endoscope." kinks in the needle can occur if the device experiences excessive pressure during product handling/preparation.The instructions for use states under system preparation: "advance stylet until resistance is felt to ensure stylet is flush with proximal fiducial marker.Note: excessive pressure on stylet may result in premature deployment." the user stated that there were two different techniques applied to the device during use.During the first technique the needle was advanced into the position to create a space and then the needle was retracted back.Once the needle was retracted back, the user attempted to deploy the fiducials.It should also be noted that the user stated that the tumor was "quite hard".It is possible that if the needle was against or inside a hard mass while the user might have been applying force and possibly manipulating the directional controls of the endoscope to get the needle in place this could have contributed to bending of the needle near the distal end.This contributes to advancement and/or retraction difficulties.The second technique that was applied to the device was pushing on the fiducials while pulling the needle back.The instructions for use states, "advance needle into target site by advancing needle handle to pre-positioned safety ring.To place a fiducial, depress thumb ring while stabilizing stylet.Continue applying pressure until tactile feedback and ultrasound visualization indicates fiducial has been deployed.Fluoroscopy may also be used to aid in visualizing placement of fiducials." prior to distribution, all echotip ultra fiducial needles are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

During an endoscopic ultrasonography (eus), the physician used three cook echotip ultra fiducial needles.Three (3) of each of the same lot number were used and all three (3) were extremely difficult to push or advance the fiducials out the tip of the sheath.The endoscope was straight, the c-channel or opening where the fiducials are exposed was on the outer curve (the needle was in the right angle for the easiest deployment of the fiducials).The tumor was quite hard, but both the physician and assistant were pushing with a straight endoscope and with two (2) other techniques.The first technique was pushing the needle in to create a space, then pulling the needle back, then pushing the fiducials.The second technique was pushing the fiducial while pulling the needle back.Both techniques were unsuccessful and a fourth needle from a different lot number was used.All techniques and conditions above were used on the fourth needle.It was not as difficult to advance the fiducials either in the tumor or on the margins.The physician was able to push the fiducials out of the three (3) needles used earlier outside of the endoscope and also one time just pushing it out the tip of the needle in front of the endoscope into the lumen of the digestive tract (not puncturing the wall yet), just to see if it would go out.In the end, the fourth needle was able to successfully place three (3) fiducials.There was no reportable information at this time.The devices were received for evaluation on 27-jun-2018 and two (2) of the devices returned had a significant bend in the distal tip (subject of this report).Other than the deployed fiducials, a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ECHOTIP ULTRA FIDUCIAL NEEDLE
• Type of Device: NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7802368
• MDR Text Key: 118101492
• Report Number: 1037905-2018-00370
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)190124(10)W4018782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2019
• Device Model Number: G03793
• Device Catalogue Number: ECHO-22-F
• Device Lot Number: W4018782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• 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