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

Model Number	G47614
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook fusion omni-tome sphincterotome, fs-omni, cook fusion quattro extraction balloon, fs-qeb-xl-a.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.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: 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.The instructions for use instruct the user to do the following: "prior to removing wire guide from holder, flush with 30 cc of sterile water." failure to flush the wire guide can result in damage to 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: 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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat 2 calibrated tip wire guide.This case was with a patient with down syndrome and a little abnormal anatomy.The user placed a wire guide with a cook fusion omni sphincterotome (fs-omni).Contrast was used.When splitting, a loop on the wire lock formed once.Then, when using the cook fusion quattro extraction balloon (fs-qeb-xl-a), it happened once again.Contrast used again.There was no reportable information at this time.The following additional information was received on 12/11/17: wire guide access to the common bile duct was lost during this case.

• 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: 7139058
• Report Number: 1037905-2017-00764
• Device Sequence Number: 13775598
• Product Code: OCY
• UDI-Device Identifier: 00827002476141
• UDI-Public: (01)00827002476141(17)200602(10)W3865916
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 12/21/2017

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: G47614
• Device Catalogue Number: AWG2-35-260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2017
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1