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

Model Number	M00569810
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A wallstent biliary rx uncovered stent and delivery system were received for analysis.The stent was returned fully deployed.However, a media inspection was performed of a photo provided by the customer and it was observed that the stent was partially deployed.Visual examination of the returned device found the outer clear sheath was accordioned.Microscopic inspection was performed and found the wires of the stent were damaged.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed; as per media inspection, the stent was found partially deployed on the delivery system.The damages noted to the stent and the outer sheath were most likely due to procedural factors.It may be that lesion characteristics, how the device was handled, the technique used by the physician and/or normal procedural difficulties encountered during the procedure, limited the performance of the device and contributed to the reported event and the observed failures.The physician might have felt some resistance while attempting to deploy the stent inside the patient and as a result, the stent could not be fully deployed.While trying to reposition the stent, this could have caused damage to the stent wires and the outer sheath (accordion).It is likely that the physician may have deployed the stent outside the patient after the procedure and the device was returned completely deployed.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.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary rx uncovered stent was to be implanted to treat a malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the wallstent biliary stent could not be fully deployed.The wallstent biliary stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another wallstent biliary stent.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation result which revealed the stent wires were damaged.

• Brand Name: WALLSTENT RX 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: 15188677
• Report Number: 3005099803-2022-04390
• Device Sequence Number: 20225365
• Product Code: FGE
• UDI-Device Identifier: 08714729456728
• UDI-Public: 08714729456728
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K030107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2022

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: 05/10/2023
• Device Model Number: M00569810
• Device Catalogue Number: 6981
• Device Lot Number: 0028353251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 65 KG