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

Model Number	G47615
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Prior to distribution, all acrobat 2 calibrated tip wire guides are subjected to a visual inspection to ensure device integrity.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.There have been no other similar occurrences reported during the time period reviewed.Therefore, this report represents an isolated occurrence.Based on this review, the likelihood of this type of report is remote.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook acrobat 2 calibrated tip wire guide.During a discussion the physician regarding the acrobat 2 device and the cook suretome (captured in mdr 1037905-2026-00106), the physician discussed many aspects of ercp techniques and considerations.He mentioned near the end of the visit an instance in which he was using a wire guide, which perforated the liver duct.He said it was stiffer than he expected and it just "sailed out".He also said it didn't "knuckle" like he expected (which we interpret as rotating or orienting the tip).Upon further discussion, it was determined that this event was previously reported under mdr 1037905-2026-00106 for the cook suretome.This mdr is being sent to capture the cook acrobat 2, since it was not originally reported by the initial reporter and it is unable to be determined which device caused or contributed.The patient will require a second ercp to retrieve the plastic stent that was placed.There was an intrahepatic ductal perforation noted on fluoro where the wire terminated.

• 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: 24744617
• Report Number: 1037905-2026-00154
• Device Sequence Number: 21009469
• Product Code: OCY
• UDI-Device Identifier: 00827002476158
• UDI-Public: (01)00827002476158(17)281201(10)W4989941
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G47615
• Device Catalogue Number: AWG2-35-260-A
• Device Lot Number: W4989941
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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: COOK SURETOME; ENDOSCOPE - UNKNOWN MAKE OR MODEL
• Patient Sex: Unknown