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

Model Number	G47617
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: olympus, pr-104q-1, reusable cannula.Mtw ercp catheter, unknown model.Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.The report was confirmed with the pictures provided.The wire guide is peeled and folded over itself revealing bare core wire around 5 to 6 cm from the distal end of the device.The wire guide is bent at the distal tip as well as approximately 16 cm from the distal end of the device.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos provided and statements describing the event.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 user indicated the wire guide was used with a pr-104q-1/olympus device.This device is compatible with.025" wire guides.The complaint device is an.035" wire guide, therefore it was not compatible with this accessory.Use with a non-compatible accessory is the most likely root cause of the wire guide coating damage.The instructions for use indicate "proceed with exchange of compatible wire-guided accessories over wire guide".Prior to distribution, all cook 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: 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.Based on the information provided that this device was used with a non-compatible accessory, 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 retrograde cholangiopancreatography (ercp) procedure, the physician used a cook acrobat® 2 calibrated tip wire guide.The device was advanced over another manufacturers ercp catheter, after removing the catheter, a contrast tube that does not have metal tips, was advanced over the complaint wire guide.Afterward, the physician accessed the stricture with the complaint wire guide but could not pass through the stricture.The operability of the wire guide was not good and the tip of the wire guide was gradually deformed, so they physician cancelled using it.After removing the complaint wire guide from the patients body, he confirmed that the coating material of the wire guide peeled off.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: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9434203
• Report Number: 1037905-2019-00751
• Device Sequence Number: 1672240
• Product Code: OCY
• UDI-Device Identifier: 00827002476172
• UDI-Public: (01)00827002476172(17)220426(10)W4208292
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2022
• Device Model Number: G47617
• Device Catalogue Number: AWG2-35-450-A
• Device Lot Number: W4208292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1