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

Model Number G47617

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: olympus forceps fg-44nr-1, olympus visiglide, model unknown, 7fr pre-existing stent, make and model unknown, ercp catheter, unknown make and model.Non-healthcare professional.Investigation evaluation: our evaluation of the product said to be involved determined that the coating damage is in a non reportable location; but access to the guide wire was lost.Approximately 21.0 cm to 23.3 cm from the distal end, 24.2 cm to 24.6 cm from the distal end, and 25.4 cm to 25.5 cm from the distal end is a section of bare core wire.Approximately 26.2 cm to 35.5 cm from the distal end, the wire guide covering has accordioned.The wire guide is bent approximately 2 cm from the distal end and approximately 13 cm to 24 cm from the distal end.Small pieces of fraying coating are approximately 21.4 cm, 21.8 cm, and 25.8 cm.Rough surfaces are found throughout the entire length of the wire guide.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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: the report states that this incident occurred while using this product with an metal tip device, fg-44nr-1 forceps.As we interpret the users report the wire guide was left in place while the forceps were used along side the wire guide.This is the most likely cause for the reported observation.The instructions for use for this product line caution the user: "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 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.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.Additional information regarding this report: based on the information provided that the wire guide was left in place while the forceps were used along side the wire guide [used with a metal device,] 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 an endoscopic procedure, the physician used a cook acrobat® 2 calibrated tip wire guide.An endoscope was inserted and the user observed a 7fr pre-existing stent [[reference product number (rpn), manufacturer unknown] in the common bile duct.Then the endoscopic retrograde cholangiopancreatography (ercp) catheter [rpn and manufacturer unknown] was advanced aside of the stent in the common bile duct.After that the ercp catheter was removed while the cook wire guide [awg2-35-450-a] remained there.A pair of forceps was then advanced to the stent and the physician attempted to grasp the stent with the forceps but he felt strong resistance, so he removed the forceps, the stent, and the wire together to outside the body [lost wire guide access, subject of this report].The user checked the wire and found that the coating material of the cook wire guide [awg2-35-450-a] came off.The procedure was completed with an another manufacturers wire guide and the stent replacement was complete.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): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 9438873
• MDR Text Key: 220343964
• Report Number: 1037905-2019-00752
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002476172
• UDI-Public: (01)00827002476172(17)220426(10)W4208288
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2019

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 Expiration Date: 04/26/2022
• Device Model Number: G47617
• Device Catalogue Number: AWG2-35-450-A
• Device Lot Number: W4208288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2019
• 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