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	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant product: boston scientific rx44 sphincterotome.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: "flush endoscope accessory channel and/or lumen of device with sterile water, then insert wire guide floppy end first.Note: for best results, wire guide should be kept wet, if applicable." prior to distribution, all 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.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat 2 calibrated tip wire guide.When the sphincterotome was being pulled out, the wire guide was coming out with it [the sphincterotome] at the wire lock.They were able to work it back and forth to get in position.The following additional information was received from the cook area representative on 7/20/17: ductal access was lost and i think it is important to mention that the sphincterotome was another manufacturer's device.I feel that the issue is a compatibility issue with this particular sphincterotome.

• 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: 6765183
• Report Number: 1037905-2017-00526
• Device Sequence Number: 16660313
• Product Code: OCY
• UDI-Device Identifier: 00827002476141
• UDI-Public: (01)00827002476141(17)200607(10)W3868089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 07/18/2017
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1