MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	H965430600
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr 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 stricture in the mid common bile duct during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during stent deployment, one of the stent wire came out and perforated the outer sheath, and then the stent was not released from the delivery system.The wallstent device was removed from the patient and a different device was used to complete the procedure.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.
Additional Manufacturer Narrative
A fully constrained wallstent biliary uncovered stent and delivery system were received for analysis.Visual examination of the returned device found the blue outer sheath at the distal section was perforated by the stent wires.A severe kink was noted in the middle of the blue exterior tube.Functional evaluation revealed it was not possible to deploy the stent due to stent wires perforating the outer sheath at the distal section.No other issues with the device were noted.The reported event was confirmed.It is possible that, upon deployment/reconstrainment attempts, the end of the stent wires got stuck, causing the perforation of the outer sheath and the resultant inability to deploy the stent.Taking all available information into consideration, the investigation concluded that the observed failures and the reported events were likely due to anatomical or procedural factors encountered during the procedure, such as tight/tortuous anatomy, which limited the performance of the device.Therefore, the most probable root cause is operational context.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.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
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 stricture in the mid common bile duct during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during stent deployment, one of the stent wire came out and perforated the outer sheath, and then the stent was not released from the delivery system.The wallstent device was removed from the patient and a different device was used to complete the procedure.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.

• Brand Name: WALLSTENT¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7683767
• Report Number: 3005099803-2018-02233
• Device Sequence Number: 18994067
• 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): 06/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2020
• Device Model Number: H965430600
• Device Catalogue Number: 43060
• Device Lot Number: 0021661224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1