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

Catalog Number METII-35-480

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report based on the condition of the returned device.The device was returned cut into 2 sections, as described in the "description of events." the device had been cut 47.7 cm from the distal tip.A small segment of coating was present on the proximal end of the distal segment of the wire guide.For measurement the distal and proximal segments were placed end to end.Segments of coating have accordioned 26.4 cm to 48.9 cm and 53.2 cm to 59.9 cm from the distal tip.The accordioned section and coating damage is likely related to the difficulty experienced by the user.The coating is damaged with the core wire exposed 47.7 cm to 52.8 cm from the distal tip.A spot of coating damage exposing the core wire was located 181.6 to 181.7 cm from the distal tip.While the coating has accordioned, no segment appears to be missing.Dimensional verification confirmed the sum of the length of the 2 segments was 479.9 cm, which is within specifications.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 conclusion: a visual examination of the wire guide confirmed difficulty experienced by the customer.The damage to the wire guide was due to the use of the wire guide with a metal tipped device, the "patient/event info - notes" report the use of an eus needle.The ifu states: "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." additionally, the "patient/event info - notes" states the wire guide was placed in the stomach.The ifu states the intended use: "this device is used to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ercp." prior to distribution, all tracer metro direct wire guides 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 and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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 wire guide was used with an eus needle device and that the wire guide was placed in the stomach, 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 a cystogastrostomy, the physician used a cook tracer metro direct wire guide.It was reported that the wire sheared in the patient.No part broke off.The coating stayed on.The wire was cut by the physician outside of the patient/scope in order to remove it from a boston scientific axios stent that was also outside of the patient/scope.The wire had been stuck in the stent [subject of report].The procedure was successfully completed with another device of the same type.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.

• Brand Name: TRACER METRO DIRECT WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105
• MDR Report Key: 16910142
• MDR Text Key: 314978456
• Report Number: 1037905-2023-00213
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002256863
• UDI-Public: (01)10827002256863(17)251206(10)W4662524
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: METII-35-480
• Device Lot Number: W4662524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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: BOSTON SCIENTIFIC AXIOS STENT.; OLYMPUS LINEAR EUS SCOPE.