MAUDE Adverse Event Report: COOK INC FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Customer reported that a patient was undergoing placement of a fanelli biliary stent for an unspecified indication.The customer reports that the device was successfully placed within the patients' common bile duct.The physician states "i deployed the stent in accordance with manufactures instructions and the metal markers on the stent deployment system came off and are in the common bile duct." the physician expected to have a gastroenterologist performed an ercp to not only clear the duct but to retrieve the metal pieces.The physician subsequently reported that the metal seen after initial deployment of the device was gone at the time of the follow-up ercp and opines that the devices 'apparently passed.' there are no reports of any adverse patient consequences.The device is reportedly available for evaluation, however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
After further review of the record, it was determined this event was previously reported under mfr.Report: 1820334-2017-01271.Any additional information relevant to this event and all further investigation will be reported under that mfr.Report.Mdr # 1820334-2017-01480 was determined to be a duplicate of mdr # 1820334-2017-01271.

• Brand Name: FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6659800
• Report Number: 1820334-2017-01480
• Device Sequence Number: 10992907
• Product Code: FGE
• UDI-Device Identifier: 00827002136991
• UDI-Public: (01)00827002136991(17)191118(10)7456263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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: N/A
• Device Catalogue Number: C-FBSS-100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention