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

Catalog Number WCHO-22-F

Device Problems Kinked (1339); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

During an endoscopic ultrasonography (eus), a cook echotip ultra fiducial needle was used.The lesion was located and the needle was placed down on the endoscope.The needle was being utilized at the difficult angle and a metal stent was preset in the same area as the lesion.Additional information provided stated the user did not lock the safety handle ring.The needle was extended 3-5 cm during attempted deployment of the fiducials.Upon attempting to deploy the fiducials, the fiducials would not deploy.They attempted to reposition and the needle kinked.The needle was removed and the case was completed successfully with another of the same type of device.A second 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 distal 3.5cm of the needle is kinked.During the laboratory evaluation, the needle was disconnected from the handle cannula at the glue joint.There was glue present at the joint as intended.All four fiducial supplied with the device were still in the distal tip.Approximately 2 mm of the first fiducial eas extended from the distal tip.The stylet was bent approximately 2 mm from the proximal end of the handle.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 or 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.According to the report, the user did not lock the safety ring.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 said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered unusual.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.Additional comments regarding this report: based on the information provided, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: ECHOTIP ULTRA FIDUCIAL NEEDLE
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE, BIOPSY NEEDLE KIT
• Manufacturer (Section D): WILSON-COOK MEDICAL; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4262157
• MDR Text Key: 5034635
• Report Number: 1037905-2014-00431
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2015
• Device Catalogue Number: WCHO-22-F
• Device Lot Number: W3447099
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1