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 Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2015

Event Type  malfunction  

Event Description

During an endoscopic ultrasonography (eus) the physician used a cook echotip ultra fiducial needle.The device was advanced through the endoscope.Upon trying to retract the needle before fiducial placement, the needle became stuck and would not retract.Another device of the same type was used to complete the procedure.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

Investigation evaluation: our evaluation of the returned device confirmed the report.The handle would advance and retract but the needle would not move.The needle was outside the distal end of the sheath approximately 5 cm.The stylet was approximately 8 cm outside the proximal end of the handle.All four fiducials supplied with the device were still inside the distal end of the needle.The needle tip was intact and no damage was observed.The handle was disassembled.The needle had separated from the handle cannula inside the handle.The joint between the needle and the handle cannula was examined.There was adhesive present as intended on the needle were it is inserted into the handle during assembly.The needle was stuck in the sheath and required extra force to remove from the sheath.There were multiple bends along the length of the needle.Also residue that appeared to be blood was found on the needle approximately 50 em from the distal 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 number said to be 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 states,"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 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 involved met all manufacturing requirements prior to shipment corrective action: a review of the complaint history was conducted and this represents an unusual 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, manager ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4563610
• MDR Text Key: 17575046
• Report Number: 1037905-2015-00070
• 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: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Catalogue Number: ECHO-22-F
• Device Lot Number: W3449637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/26/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2014
• 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 ENDOSCOPE (UNK MODEL NUMBER)
• Patient Age: 60 YR