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

Model Number	G03421
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a miller double mushroom biliary stent set was difficult to remove in an antegrade direction while stenting the bile duct due to cholangitis stricture of the common bile duct.A section for the device remained in the patient and was removed in to the small bowel to pass.As reported, the patient did not require an additional procedure or experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.Additional information: patient's age: 37 years; date of birth: 10/13/1980.Date of event: (b)(6) 2017.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.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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.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 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: 7443743
• Report Number: 1820334-2018-00999
• Device Sequence Number: 19106168
• 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: Physician
• Type of Report: Initial,Followup,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: 04/30/2018; 08/21/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 07/25/2018; 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: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 100