MAUDE Adverse Event Report: COOK ENDOSCOPY TRACER METRO DIRECT WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number METII-35-480

Device Problems Peeled/Delaminated (1454); Off-Label Use (1494); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: cook classic ercp catheter (ercp-1-bt), forcep (unknown make or model).Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined, however the use error most likely contributed to the failure.Specifically, the user indicated the wire guide was used with an ercp-1-bt, which contains a metal tip.The instructions for use contain the following precaution "use of this wire guide with metal tip ercp devices may result in damage to the external coating and/or tip of the wire guide." in addition the user indicated a forcep was used to pull the wire guide into an endoscope, the metal forceps head could have contributed to the wire guide coating damage.Prior to distribution, all cook tracer metro direct wire guides are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.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 that the device was used off label and the device was used with metal tip ercp devices, 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.

Event Description

During an gastrointestinal/interventional radiology procedure, the physician used a cook tracer metro direct wire guide.The user placed a wire through a catheter to gain access to the hepatic duct, and then placed the wire through the common bile duct.The wire guide exited the ampulla and the user drew the wire guide into a duodenal endoscope using a forcep.A cook classic ercp catheter (ercp-1-bt) [was advanced] over the proximal end of the wire, [and] the coating sheared in a couple of different places on the wire [coating damage].No portion of the wire detached or had to be removed from the patient.[based off the description, it appears a rendezvous procedure was being performed, which is off label.] the procedure was aborted at this point and the patient returned at a later date to complete the procedure.This second procedure was successful.

Manufacturer Narrative

An emdr report was initially sent on 3/03/17, based on the following information."during an gastrointestinal/interventional radiology procedure, the physician used a cook tracer metro direct wire guide.The user placed a wire through a catheter to gain access to the hepatic duct, and then placed the wire through the common bile duct.The wire guide exited the ampulla and the user drew the wire guide into a duodenal endoscope using a forcep.A cook classic ercp catheter (ercp-1-bt) [was advanced] over the proximal end of the wire, [and] the coating sheared in a couple of different places on the wire [coating damage].No portion of the wire detached or had to be removed from the patient.[based off the description, it appears a rendezvous procedure was being performed, which is off label.] the procedure was aborted at this point and the patient returned at a later date to complete the procedure.This second procedure was successful.The following clarification was received on 3/16/17: "the location of the damage occurred at the user end, in the multi-colored spiral coating and the user drew the wire using a forcep into the endoscope because this is what they have done in the past with success." the event was reported for wire guide coating damage that could lead to potential detachment of the wire guide tip.The metii-35-480 wire guide has a tip that extends 5.5 cm and is coated in black material.In this case, the damage to the wire guide coating occurred occur at the user end, in the multi-colored spiral coating.Therefore, it is unlikely that the damage to the coating at this location could lead to detachment of the tip.Based on the clarification received, this incident no longer meets the reporting criteria of an fda mdr report.

Event Description

This follow up report is being sent to cancel the initial report submitted relating to this event.Please reference the additional manufacturer narrative notes for this justification.

• Brand Name: TRACER METRO DIRECT WIRE GUIDE
• Type of Device: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 6376871
• MDR Text Key: 69109526
• Report Number: 1037905-2017-00087
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: METII-35-480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/03/2017
• Event Location: Hospital
• Date Manufacturer Received: 03/16/2017
• 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
• Treatment: OLYMPUS ENDOSCOPE, UNKNOWN MODEL