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

Model Number	H965431100
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been retained and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallstent biliary partially covered stent was to be used to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician was able to deploy the stent.However, when the stent was more than halfway released, the physician experienced difficulty in deploying the proximal part of the stent.The physician also noted that the order of the stent wires were irregular.A part at one end of the stent was found ¿not properly weaved¿ and a wire was sticking out.The stent was removed from the patient and the procedure was completed with another wallstent biliary stent.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 deployed wallstent biliary partially covered stent and delivery system were returned for analysis.Visual examination of the returned device found the stent wires on one side were uncrossed.The inner shaft and the outer sheath were kinked.No other issues noted with the device.The damages noted with the device were consistent with the application of excessive force during use.The investigation concluded that the observed failures are likely due to anatomical or procedural factors encountered during the deployment 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 similar complaints exist for the specified lot.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallstent biliary partially covered stent was to be used to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician was able to deploy the stent.However, when the stent was more than halfway released, the physician experienced difficulty in deploying the proximal part of the stent.The physician also noted that the order of the stent wires were irregular.A part at one end of the stent was found ¿not properly weaved¿ and a wire was sticking out.The stent was removed from the patient and the procedure was completed with another wallstent biliary stent.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: 7096381
• Report Number: 3005099803-2017-03688
• Device Sequence Number: 19316179
• Product Code: FGE
• UDI-Device Identifier: 08714729317937
• UDI-Public: 08714729317937
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K000308
• 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): 11/15/2017

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: 05/03/2019
• Device Model Number: H965431100
• Device Catalogue Number: 43110
• Device Lot Number: 0020596572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 03/07/2018
• 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