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 Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the thumb ring stylet wire bent and hanging out of the proximal end of the handle.The needle adjuster was placed on "8" and the needle was advanced outside the distal end of the sheath.The needle was bent with significant deflection the length of the needle outside the distal end of the sheath.A visual inspection of the device was performed and all four fiducials were returned and not deployed.One of the fiducials was partially deployed with the fiducial past the tip of the needle.A bend in the sheath was observed at 3.2 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.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 would advance and retract 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, and deployment was successful.A dimensional verification under magnification was performed on the needle, the slot the fiducials are 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 being deployed meets the specification.The large slot which the fiducials rest in prior to deployment meets the specification.There were four (4) fiducials returned.All four (4) fiducials were within specification for length.All four (4) met the specification for the tab length.The overall height of all four (4) are within specification.The tab width of all four (4) fiducials are within 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 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: "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." it is possible that if the needle is against or inside a hard mass, while the user applies force and manipulates the directional controls of the endoscope, this could contribute to severe bending of the needle near the distal end.This contributes to advancement and/or retraction difficulties.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." 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 a cook echotip ultra fiducial needle.As reported to customer relations: "[the user] was in position to place fiducials in the head of pancreas.The doctor went to place [the fiducials] and found it really hard to push the stylet.He adjusted the position, and continued to try to push the fiducials out and they would not go.At this point, the stylet was bent.The device was removed and another device was used with no further issues." the additional information provided indicates the needle had a kink or bend at the patient end of the device.

• 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7094984
• MDR Text Key: 94638152
• Report Number: 1037905-2017-00743
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00827002037939
• UDI-Public: (01)00827002037939(17)180823(10)W3904474
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2017

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: G03793
• Device Catalogue Number: ECHO-22-F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• 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