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

Model Number	G26862
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook tracer metro direct wire guide.It was reported that the wire guide was placed in the pancreatic duct, but the wire guide became unable to pass midway.Use of device was discontinued [loss of wire guide access], and the procedure was completed using other products.Per evaluation of product return on 4 feb 2025, damage to the proximal wire guide coating was noted.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.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.The product was returned with a dlb-21-1.5-s cytology brush device.Our evaluation of the product said to be involved confirmed the report.The device was returned advanced into the provided dlb-21-1.5-s, however it was noted that the proximal end of the wire guide is not advanced out of the proximal end of the dlb-21-1.5-s.When attempting to advance the wire guide out of the proximal end, resistance was encountered.The wire guide was removed, the wire guide lumen of the dlb-21-1.5-s was flushed, and advancement was reattempted.However, the proximal end of the wire guide, again, failed to pass through the proximal end of the dlb-21-1.5-s.The wire guide was viewed under magnification, and buckling of the proximal coating was noted, confirming evidence of difficulty experienced by the user.However, it could not be determined if the buckling was the cause of, or the result of, the resistance experienced when advancing through the dlb-21-1.5-s.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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: our evaluation of the product said to be involved confirmed the report.Resistance was encountered when attempting to advance the provided dlb-21-1.5-s and buckling of the proximal coating was noted, confirming evidence of difficulty experienced by the user.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.Prior to distribution, all d.A.S.H.Dometip double lumen sphincterotomes preloaded with tracer metro direct wire guides 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Our evaluation of the product said to be involved confirmed the report.The device was returned advanced in to the provided dlb-21-1.5-s, however it was noted the proximal end of the wire guide is not advanced out of the proximal end of the dlb-21-1.5-s.When attempting to advance the wire guide out of the proximal end, resistance was encountered.The wire guide was removed, the wire guide lumen of the dlb-21-1.5-s was flushed, and advancement was reattempted.However, the proximal end of the wire guide, again, failed to pass through the proximal end of the dlb-21-1.5-s.The wire guide was viewed under magnification, and buckling of the proximal coating was noted, confirming evidence of difficulty experienced by the user.However, it could not be determined if the buckling was the cause of, or the result of, the resistance experienced when advancing through the dlb-21-1.5-s.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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: our evaluation of the product said to be involved confirmed the report.Resistance was encountered when attempting to advance the provide dlb-21-1.5-s and buckling of the proximal coating was noted, confirming evidence of difficulty experienced by the user.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.Prior to distribution, all tracer metro direct wire guides 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• Brand Name: TRACER METRO DIRECT WIRE GUIDE
• Common Device Name: 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 (COOK ENDOSCOPY); 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 21462205
• Report Number: 1037905-2025-00166
• Device Sequence Number: 15501070
• Product Code: OCY
• UDI-Device Identifier: 00827002268623
• UDI-Public: (01)00827002268623(17)270719(10)W4855313
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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
• Operator of Device: Health Professional
• Device Model Number: G26862
• Device Catalogue Number: METII-21-480
• Device Lot Number: W4855313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK DLB-21-1.5-S - CYTOLOGY BRUSH.; OLYMPUS TJF-Q290V SCOPE.
• Patient Sex: Unknown