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); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be implanted to treat a malignant stricture in the bile duct during a biliary stent implantation procedure performed on (b)(6) 2022.During the procedure, the outer sheath was damaged and the stent delivery system was unable to cross the stricture.The stent was removed from the patient fully covered by the outer sheath.The procedure was completed with another wallstent biliary.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.This event has been deemed a mdr-reportable event based on investigation results which revealed that the stent wire punctured the clear outer sheath of the delivery system.
Additional Manufacturer Narrative
(b)(4).A wallstent biliary uncovered stent and delivery system were returned for analysis.The stent was received partially deployed.Visual examination of the returned device found stretch marks on the outer clear sheath and one stent wire puncturing the outer clear sheath.A dimensional inspection was performed and the distal section of the outer diameter of the delivery system was found to be out of specification.No other damages with the stent and delivery system were noted.The reported event of sheath damaged was confirmed; during visual inspection stretch marks were found on the outer clear sheath.The reported event of difficulty crossing lesion could not be confirmed; the event occurred during the procedure and it is not possible to replicate in the laboratory of analysis.The damages noted on the returned device were most likely due to procedural factors encountered during the procedure.It may be that handling and manipulation of the device, the techniques used by the user, the characteristics of the lesion and normal procedural difficulties encountered during procedure, limited the performance of the device and contributed to the sheath damage and stent wire puncture of the outer clear sheath.This could lead to incomplete deployment and the partially deployed stent could have caused the outer diameter of the clear sheath to be out of specification in the distal section.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14088631
• Report Number: 3005099803-2022-01963
• Device Sequence Number: 12081399
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K982184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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: 07/20/2023
• Device Model Number: H965430600
• Device Catalogue Number: 3060
• Device Lot Number: 0027698966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 71 KG