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

Model Number	H965430600
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallstent biliary uncovered stent and delivery system were returned for analysis.The stent was received not deployed.It was noted that stent wires were uncrossed inside the sheath.A visual inspection identified uncrossed wires and kinked wires at the two ends of the stent.Functional evaluation revealed that it was possible to deploy the stent using the delivery system as received.No other issues were noted with the stent and delivery system.The damages noted with the returned device were consistent with the application of excessive force during use.The investigation concluded that the observed failures were likely caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation or shipping.Therefore, the most probable root cause is handling damage.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 that a wallstent biliary uncovered stent was to be used in the bile duct during a percutaneous transhepatic choangiography and biliary drainage (ptcd) with stenting procedure performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, the stent was tested for its deployment mechanism.Apparently, the stent failed to deploy; it would not open up smoothly and high resistance was encountered during deployment.Reportedly, the procedure was completed with another wallstent biliary stent.There were no patient complications reported as result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed uncrossed wires and kinked wires at the two ends of the stent.

• Brand Name: WALLSTENT¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7802950
• Report Number: 3005099803-2018-02552
• Device Sequence Number: 2507469
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Report Date (Section B): 08/03/2018

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: 06/02/2018
• Device Model Number: H965430600
• Device Catalogue Number: 43060
• Device Lot Number: 0019328496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1