MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACROBAT¿ 2 CALIBRATED TIP WIRE GUIDE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G47616
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the pictures provided with this report because the product said to be involved was not provided to cook for evaluation.A photo of the lot number was not provided.Our evaluation of the photos provided confirmed the report.The photos show the wire guide advanced into an accessory device.The wire guide coating is damaged, exposing the core wire proximal to the five-band marker.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 photos provided confirmed the report.However, we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.The report states that this incident occurred while using this product to place a stent and that the wire guide was used with metal tipped ercp accessories.This is the most likely cause for the reported observation.The instructions for use for this product indicate: "this device is used to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ercp." additionally, the instructions for use cautions: "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." prior to distribution, all acrobat® 2 calibrated tip 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 comments: based on the information provided that this incident occurred while using this product to place a stent and that the wire guide was used with metal tipped ercp accessories, 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 or Problem Description
During an endoscopic cystic gastrostomy procedure, the physician used a cook acrobat® 2 calibrated tip wire guide.It was reported that the axios installation system got stuck and both the axios and wire guide assembly had to be removed from the endoscope.The wire guide was stuck in the axios system.[loss of wire guide access].A picture of the device showing wire guide coating damage was provided.[subject of report] 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: ACROBAT¿ 2 CALIBRATED TIP 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; 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: 22367931
• Report Number: 1037905-2025-00484
• Device Sequence Number: 15460011
• Product Code: OCY
• UDI-Device Identifier: 00827002476165
• UDI-Public: (01)00827002476165(17)280214(10)W4914220
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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: G47616
• Device Catalogue Number: AWG2-35-450
• Device Lot Number: W4914220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2025
• 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: BOSTON SCIENTIFIC HOT AXIOS STENT.; SCOPE, UNKNOWN MAKE OR MODEL.
• Patient Sex: Unknown