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

Catalog Number AWG2-25-450

Device Problem Peeled/Delaminated (1454)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the picture 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 photo provided confirmed the report.The coating of the wire guide has split exposing the core wire.The two (2) band marker, which is located approximately 10 cm from the distal tip, is visible near the damage.Coating damage is noted on both sides of the two (2) band marker, though one side is a small area and the other is a long split segment.However, due to the condition of the device we are unable to determine if the majority of damage is proximal or distal to the two (2) band marker.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: our evaluation of the image provided confirmed the report of coating damage.The user states that pressure was being applied to the wire guide by the endoscope elevator, this is a likely cause of the coating damage observed.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all acrobat® 2 calibrated tip wire guides are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted.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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook acrobat® 2 calibrated tip wire guide.It was reported that the physician performed a sphincterotomy, and about 3-4 balloon sweeps, he noticed the wire looking like it had ¿split¿.Procedure went ok, and no adverse events took place.Physician did not complain about the wire, and believed that it may have been because of the elevator in the scope being pushed up on the wire as it was pulled out.An image of the device was provided to show the coating damage.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
• 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): 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: 18908871
• MDR Text Key: 337793673
• Report Number: 1037905-2024-00154
• Device Sequence Number: 1
• Product Code: OCY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

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: AWG2-25-450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ENDOSCOPE, UNKNOWN MAKE OR MODEL