MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ECHOTIP ULTRA FIDUCIAL NEEDLE; NEU, MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT

Catalog Number ECHO-22-F

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

During the endoscopic ultrasonography (eus), the physician used a cook echotip ultra fiducial needle for fiducial placement in the head of the pancreas.The needle was put down the endoscope and could not penetrate the lesion easily.The fiducials were difficult to deploy and the stylets that push out the fiducials bent or kinked.The needle broke completely (stuck out of sheath even when the handle is pulled back) and could not be retracted at all.The procedure was completed, but the physician was not able to place as many fiducials as she wanted.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.

Manufacturer Narrative

The lot number could not be specified by the initial report.Information provided confirmed the occurrence possibly involves the following lot number: w3449637, manufacture date 07/14/2014, expiration date 07/17/2015.Investigation evaluation: our evaluation of the returned device confirmed the report.The stylet was still inside the returned needle.There is a bend in the stylet at the proximal hub.The needle was protruding from the distal end of the sheath approximately 4 cm.Two fiducials were deployed and two fiducials were still undeployed.The handle was worked in and out, however the needle would not extend or retract.The proximal end of the handle was unscrewed and the handle component was removed from the handle.The needle had separated from the handle component inside the handle.The inside of the handle component was inspected and there was adhesive inside the handle component as intended.The needle was removed from the sheath.There is a bend in the needle approximately 15 cm from the proximal end.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot potentially involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusions: 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 state, "needle must be retracted into sheath and thumbscrew on safety ring must be locked to hold needle in place prior to introduction, advancement or withdrawal of device." "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." "device may not be used prior to training by manufacturer." "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 needle tip can slowly be retracted and advance into another site to place additional fiducials as needed." the instructions for use state, "attach device to accessory channel port." the instructions for use also cautions the user that, "failure to attach device prior to needle adjustment or extension may result in damage to endoscope." attaching the needle to the endoscope will also aid in preserving the device integrity and function.It is possible that if 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 can contribute to advancement and/or retraction difficulties.Kinks in the needle can occur if the device experiences excessive pressure during product handling/preparation.Prior to distribution, all echotip ultra fiducial needles are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot potentially involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4438507
• MDR Text Key: 19406138
• Report Number: 1037905-2015-00017
• Device Sequence Number: 1
• Product Code: NEU
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-22-F
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: OLYMPUS 180 EUS ENDOSCOPE