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

Model Number	H965430600
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An wallstent biliary stent and delivery system were received for analysis.The stent was received fully covered by the outer sheath and undeployed.Visual examination of the returned device found the outer sheath kinked approximately at 7cm from the tip of the delivery system.Microscopic examination was performed and the stent was found damaged.A functional inspection was performed and the stent was deployed by actuating the delivery system (slide the handle back along the stainless steel tube).No other issues were noted to the stent and delivery system.The damages noted of the returned device were most likely due to factors encountered during the procedure.It may be that the techniques used by the user when inserting or removing the device through the scope or some anatomical factors could have caused the physician to apply more force, limited the performance of the device and contributed to the outer sheath kinked and the damage on the stent.However, the reported event of stent failure to deploy was not confirmed.During functional analysis, the stent was deployed without resistance.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary stent was to be implanted to treat a 4 cm malignant stenosis in the bile duct during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent failed to deploy.The procedure was completed with another wallstent biliary stent.There were no patient complications as a 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 a mdr-reportable event based on investigation results which revealed that the stent wire was damaged.

• 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: 11541559
• Report Number: 3005099803-2021-01169
• Device Sequence Number: 19967666
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: 01/09/2021
• Device Model Number: H965430600
• Device Catalogue Number: 43060
• Device Lot Number: 0023164671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 52