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

Model Number G03793

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the user's report and determined a significant bend in the needle.The stylet wire and four (4) fiducials were included in the return.The stylet wire did not exhibit a bend near the proximal thumb ring handle.All four (4) fiducials were still in the needle and have not been deployed.The first fiducial was partially deployed past the tip of the needle, this may have contributed to the reported advancement difficulty and ultimately to the needle bending.The needle adjuster was placed on "8" and the needle would advance and retract 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 bend at the distal end of the device was 4.2 cm from the distal tip of the sheath.It is difficult to determine when the bend in the needle occurred.A second bend in the sheath of the device was observed at 47 cm from the distal end of the handle.The bevel of the needle appeared to be intact and uniform.During a functional test with an olympus gf-uc160p (3.2 mm channel endoscope) placed in a curved position, the needle was attempted to be advanced through the endoscope.The attempt was unsuccessful as the device would not fully advance through the distal tip of the endoscope.When the device stopped advancing through the endoscope there was a distance of 5.3 cm left between the accessory channel port and the distal end of the handle that attaches to the endoscope.The device was taken out of the endoscope and then reinserted back into the accessory channel with the endoscope in a straight position.Once again the device would not fully advance and the attempt was unsuccessful.A third attempt was performed with the endoscope in the straight position and when the device was inserted into the accessory channel, advancement through the endoscope was successful.The handle of the device was attached to the accessory channel.The needle would advance and retract when the handle was manipulated as intended.Once the needle was in the advanced position, pressure was applied to the thumb ring to deploy the fiducials.Each fiducial deployed successfully.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 conclusion: 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: "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 partially deployed fiducial may have contributed to the report of advancement difficulty and the bending of the needle.The instructions for use includes the following note: "excessive pressure on stylet may result in premature deployment." 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: based on the quality engineering risk assessment, corrective action is currently being assessed.A follow up report will be sent once the assessment is complete.

Event Description

During an endoscopic ultrasonography (eus) with fiducial placement, the physician used a cook echotip ultra fiducial needle.The physician tried to advance the needle down the endoscope.After 8 cm down the endoscope, the needle got stuck and would not advance further.They tried with a bigger catheter and the needle advanced just fine.[the user] opened a second needle and completed the procedure successfully.The [complaint] needle appeared to be intact and without a bend.There was no reportable information at this time.The following additional information was received on 12/23/17: the facility used the same endoscope and advanced a different device with a bigger catheter to determine if the scope was the issue.There was no reportable information at this time.The device was evaluated on 12/20/17.It was observed that the needle had a significant bend.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the user's report and determined a significant bend in the needle.The stylet wire and four (4) fiducials were included in the return.The stylet wire did not exhibit a bend near the proximal thumb ring handle.All four (4) fiducials were still in the needle and have not been deployed.The first fiducial was partially deployed past the tip of the needle, this may have contributed to the reported advancement difficulty and ultimately to the needle bending.The needle adjuster was placed on "8" and the needle would advance and retract 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 bend at the distal end of the device was 4.2 cm from the distal tip of the sheath.It is difficult to determine when the bend in the needle occurred.A second bend in the sheath of the device was observed at 47 cm from the distal end of the handle.The bevel of the needle appeared to be intact and uniform.During a functional test with an olympus gf-uc160p (3.2 mm channel endoscope) placed in a curved position, the needle was attempted to be advanced through the endoscope.The attempt was unsuccessful as the device would not fully advance through the distal tip of the endoscope.When the device stopped advancing through the endoscope there was a distance of 5.3 cm left between the accessory channel port and the distal end of the handle that attaches to the endoscope.The device was taken out of the endoscope and then reinserted back into the accessory channel with the endoscope in a straight position.Once again the device would not fully advance and the attempt was unsuccessful.A third attempt was performed with the endoscope in the straight position and when the device was inserted into the accessory channel, advancement through the endoscope was successful.The handle of the device was attached to the accessory channel.The needle would advance and retract when the handle was manipulated as intended.Once the needle was in the advanced position, pressure was applied to the thumb ring to deploy the fiducials.Each fiducial deployed successfully.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 conclusion: 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: "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 partially deployed fiducial may have contributed to the report of advancement difficulty and the bending of the needle.The instructions for use includes the following note: "excessive pressure on stylet may result in premature deployment." 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.

• 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
• MDR Report Key: 7185348
• MDR Text Key: 97741806
• Report Number: 1037905-2018-00014
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)181013(10)W3927516
• Combination Product (y/n): N
• PMA/PMN Number: K141356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G03793
• Device Catalogue Number: ECHO-22-F
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2017
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS EUS ENDOSCOPE