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

Model Number	G13699
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the distal flange of the stent on a fanelli laparoscopic endobiliary stent set had separated from the device.The territory manager was providing an in-service on a product and discussion occurred regarding other products used in common bile duct exploration.The fanelli laparoscopic endobiliary stent set was brought into the room for demonstration, and it was then discovered that the distal flange of the stent had separated from the device inside of the sterile packaging.No patient contact occurred.The device was stored in a clean, dry room with some lighting among other sterile wrapped products normally stored within the operating theater environment.
Additional Manufacturer Narrative
Investigation/evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), quality control, and specifications of the device, as well as a visual inspection and dimensional verification were conducted during the investigation.The visual inspection of the complaint device revealed that the flange was broken off the device and free-floating within the stent inner packaging.No other portions of the device were damaged.The device was removed from the packaging.The separated flange was broken at the connection point.The proximal flange portion of the stent was bent with minimal force and snapped easily.It seemed brittle.All dimensions related to the reported failure mode were analyzed (stent od, flange length distal/proximal) and found that the device was manufactured within cook¿s specifications.Additionally, a document based investigation evaluation was performed.The device master record was reviewed and it was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record indicate there are no non-conformances relevant to the reported failure mode.A search of complaints on the reported lot found no additional complaints from the field.Cook also reviewed product labeling.The product ifu, [c_t_fbss_rev1] ¿fanelli laparoscopic endobiliary stent system,¿ provides the following information to the user related to the reported failure mode: "how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a supplier investigation was performed for the returned device and confirmed that the flange on the stent was broken off, and the stent was separated into two pieces.The deployment and positioning catheters were found to have kinks.Complaint is suspected to be a packaging/storage issue, as per the supplier¿s dhr review, no anomalies were noted to the affected lot.No actions were taken based on the failure.Based on the information provided, inspection of the returned product and the results of the investigation, a definitive cause could not be established.Appropriate measures are being initiated to investigate this failure mode.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information has been reported.

• 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: 8374009
• Report Number: 1820334-2019-00462
• Device Sequence Number: 2287942
• Product Code: FGE
• UDI-Device Identifier: 00827002136991
• UDI-Public: (01)00827002136991(17)191028(10)7397591
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 10/28/2019
• Device Model Number: G13699
• Device Catalogue Number: C-FBSS-100
• Device Lot Number: 7397591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1