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

Catalog Number ECHO-22-F

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

During an endoscopic ultrasonography (eus), a cook echotip ultra fiducial needle was used in the pancreas.Advancing the needle into the lesion was very difficult.The needle appeared to be bent at the distal end.The stylet also appeared to have moved upward.The markers would not fire so the device was removed from the endoscope and another device 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.There is a curve in the distal end of the needle and a kink approximately 3 cm from the distal end.The four fiducial markers supplied with the device are still present in the distal tip.The most distal fiducial marker has been pushed towards the distal end such that approximately 2 mm of the fiducial marker is extended past the tip of the needle.Two of the markers are pushed up against the most distal marker.The fourth marker is separated from the three most distal markers by approximately.5 em.There are several kinks and bends in the sheath.The stylet is bent approximately 3 cm from the proximal end.No part of the device is missing.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 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,"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 advanced into another site to place additional fiducials as needed." 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 contribute to advancement and for retraction difficulties.Kinks in the needle can occur if the device experiences excessive pressure during product handling/preparation.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.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.(b)(4).

• Brand Name: ECHOTIP ULTRA FIDUCIAL NEEDLE
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT
• Manufacturer (Section D): WILSON-COOK MED INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4353473
• MDR Text Key: 19723823
• Report Number: 1037905-2014-00485
• 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: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2015
• Device Catalogue Number: ECHO-22-F
• Device Lot Number: W3456628
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/19/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/17/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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 LINEAR EUS ENDOSCOPE (UNK MODEL NUMBER)