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

Model Number	H965430600
Medical Device Problem Codes	Material Puncture/Hole (1504); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
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) 2019 that a wallstent biliary uncovered stent was to be used to treat a malignant stricture in the common bile duct due to biliary cancer during a biliary stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the wallstent was unable to cross the stricture.Reportedly, the stent was attempted to be deployed; however, the stent was not fully released.The device was removed from the patient partially covered with the outer sheath.The physician noted that the stent wire perforated and was coming out of the outer sheath of the delivery system.The procedure was completed with another wallstent biliary stent.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 1504 captures the reportable event of stent wire punctured sheath.Block h10: a wallstent biliary uncovered stent and delivery system were received for analysis.The stent was received not deployed and was fully covered by the outer sheath.Visual examination of the returned device found one of the stent wire perforated the outer sheath at the distal section.The outer sheath was pulled slightly back from the distal tip.Functional evaluation revealed that it was not possible to deploy the stent due to the stent wire perforating the outer sheath.The outer diameter of the distal section of the exterior tube (outer sheath) was measured and was found to be within specifications.No other issues with the device were noted.It is possible that during deployment/reconstrainment attempts, the end of the stent wires may have gotten stuck, causing the perforation of the outer sheath and the inability to deploy the stent.Taking all available information into consideration, the investigation concluded that the reported event and the observed failure were likely due to anatomical and procedural factors, such as characteristics of the lesion, handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is adverse event related to the procedure.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 (b)(6) 2019 that a wallstent biliary uncovered stent was to be used to treat a malignant stricture in the common bile duct due to biliary cancer during a biliary stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the wallstent was unable to cross the stricture.Reportedly, the stent was attempted to be deployed; however, the stent was not fully released.The device was removed from the patient partially covered with the outer sheath.The physician noted that the stent wire perforated and was coming out of the outer sheath of the delivery system.The procedure was completed with another wallstent biliary stent.There were no patient complications as a result of this event.

• 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: 8480413
• Report Number: 3005099803-2019-01621
• Device Sequence Number: 13869112
• 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): 09/19/2019

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: 11/23/2020
• Device Model Number: H965430600
• Device Catalogue Number: 3060
• Device Lot Number: 0022982286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1