MAUDE Adverse Event Report: COOK INC MILLER DOUBLE MUSHROOM BILIARY STENT SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G03421
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Cellulitis (1768); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - estimated to be (b)(6) 2017.Pma/510(k) #: preamendment.(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 during a biliary stent removal through a percutaneous access port, the miller double mushroom biliary stent was stuck in the biliodigestive anastomosis and difficult to remove.A small part of the stent remained in the subcutaneous tissue which required a small skin incision be made to remove this fragment.As reported, the patient developed extensive cellulitis in the abdominal region and required intravenous antibiotics for an extended period of time.
Additional Manufacturer Narrative
(b)(6).Additional information was received ((b)(6) 2018) from the customer regarding the reported incident.The customer confirmed that there were no difficulties experienced during the initial placement of the stent, and that the usual products and equipment used during this type of procedure was employed in this case as well.The date of implantation was reported to be (b)(6) 2017, and the stent was removed on (b)(6) 2017.Implant date: (b)(6) 2017, explant date: (b)(6) 2017.Investigation - evaluation a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there was one other reported complaint for this lot number.The device is shipped with instruction for use (ifu) which notes: when choosing a stent length, ensure that the length chosen will position the mushroom tips above and below the biliary lesion to be stented.Position the stent across the obstructing lesion, with biliary lesion centered between mushroom tips.It is not known if there was a ¿delay in stent introduction at least three to seven days after initial insertion of the internal/external catheter into the duodenum as per the ifu.Based on the information provided, no product returned and the results of our investigation, the possible root cause of this complaint is related to the patient anatomy, (possibly related to the pre-existing patient condition.The patient had pre-existing cholangitis stricture of the cbd) however a root cause could not be determined with certainty.We will continue to monitor for similar complaints and notify appropriate personnel.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
No new event description information to report at this time.

• Brand Name: MILLER DOUBLE MUSHROOM BILIARY STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7442516
• Report Number: 1820334-2018-01000
• Device Sequence Number: 1055823
• Product Code: FGE
• UDI-Device Identifier: 00827002034211
• UDI-Public: (01)00827002034211(17)200410(10)7815847
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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: G03421
• Device Catalogue Number: UBSS-10-7.5-MLR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 85