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 Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
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 a stent placement on (b)(6) 2017 for an unspecified indication.The customer reported that two pieces of the stent were left in the patients' common bile duct.The patient underwent an endoscopic retrograde cholangio pancreatography (ercp) and fluoroscopy at an unspecified time following the initial procedure to locate the fragments.No retained fragments were identified.The customer opines that the fragments have cleared the patient's body.No further patient or event information is available.The device was received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Investigation summary: a review of the complaint history, documentation, device history record, specifications, drawings, quality control data, instructions for use(ifu) and a visual inspection of the returned device were conducted during the investigation.The returned product was apparently damaged, missing a portion of the catheter length, and missing two marker bands.There are sufficient controls in place to ensure that the catheter was intact when it was released, and the damage is believed to have occurred during the procedure.This may have been related to user technique or difficult anatomy.An investigation was performed by the supplier and indicated that the delivery system catheter appeared to be damaged, shorter in length than specified, and missing two marker bands.It appears that a section of the catheter separated with the marker bands.Although a portion of the device was left in the patient, it appears to have naturally passed through the digestive system without complication.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no other non-conformances associated with the complaint device failure mode.There was one other reported complaint for this lot number; however, it was a duplicate complaint.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause is related to patient condition/anatomy.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6604507
• Report Number: 1820334-2017-01271
• Device Sequence Number: 16300741
• 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: health professional,other,use
• Initial Reporter Occupation: Other
• 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?: No
• 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: 05/02/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 06/01/2017
• 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
• Patient Age: 67 YR