MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	H965430600
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallstent biliary uncovered stent was to be used to treat a biliary obstruction during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stent migrated immediately after deployment.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
Additional Manufacturer Narrative
Problem code 3009 captures the reportable event of stent positioning issue.Investigation results: a fully deployed wallstent biliary stent and delivery system were received for analysis.Visual examination of the returned device found uncrossed and kinked stent wires at one end of the stent.The stent was measured to be within specifications.No other issues were noted to the stent and delivery system.The damages noted to the stent were most likely a result of unintentional use error during post procedure handling or re-packing of the device.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Stent misplacement with a failure effect of stent migration is noted within the dfu as a potential adverse events associated with the use of this device.Therefore, the most probable root cause is known inherent risk of device.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation on july 21, 2018 that a wallstent biliary uncovered stent was to be used to treat a biliary obstruction during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stent migrated immediately after deployment.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7770209
• Report Number: 3005099803-2018-02517
• Device Sequence Number: 1758111
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: H965430600
• Device Catalogue Number: 43060
• Device Lot Number: 0021929701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 07/21/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 02/20/2019
• 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