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

Model Number	H965430500
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 malignant stricture approximately 3cm long in the lower common bile duct due to cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, a 6cm wallstent was able to be deployed.However, during the removal of the assembly, the delivery system got caught on the stent.When the delivery system was pulled out from the patient, the stent came along with it instead of being deployed in the body.The procedure was completed with another wallstent biliary stent.There were no 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 deployed wallstent biliary uncovered stent and delivery system were received for analysis.Visual examination of the returned device identified uncrossed and kink stent wires on both ends.There were multiple kinks found at the distal end of the inner member.The stent was measured to be within specifications.No other issues with the device were noted.The damages noted were consistent with excessive force being applied to the delivery system.Taking all available information into consideration, the investigation concluded that the observed failures were likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly and product specifications at the time of release to distribution.A search of the complaint database revealed that no other similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation on march 24, 2018 that a wallstent biliary uncovered stent was to be used to treat a malignant stricture approximately 3cm long in the lower common bile duct due to cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, a 6cm wallstent was able to be deployed.However, during the removal of the assembly, the delivery system got caught on the stent.When the delivery system was pulled out from the patient, the stent came along with it instead of being deployed in the body.The procedure was completed with another wallstent biliary stent.There were no 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: 7423587
• Report Number: 3005099803-2018-01112
• Device Sequence Number: 37704
• Product Code: FGE
• UDI-Device Identifier: 08714729204671
• UDI-Public: 08714729204671
• 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): 03/24/2018

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: 11/30/2018
• Device Model Number: H965430500
• Device Catalogue Number: 43050
• Device Lot Number: 20024127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/24/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 60