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

Model Number	M00569690
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on december 15, 2021 that a wallstent biliary rx partially covered stent was to be implanted to treat a malignant stenosis in the upper common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, the stent deployed prematurely.The stent was removed from the patient and the procedure was completed with another wallstent biliary stent.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.
Additional Manufacturer Narrative
(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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on december 15, 2021 that a wall stent biliary rx partially covered stent was to be implanted to treat a malignant stenosis in the upper common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2021.During the procedure, the stent deployed prematurely.The stent was removed from the patient and the procedure was completed with another wallstent biliary stent.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.
Additional Manufacturer Narrative
Medical device problem code a150103 captures the reportable event of stent prematurely deployed.A wallstent biliary rx partially covered stent and delivery system were received for analysis.The stent was received fully deployed.Visual inspection found the outer clear sheath was kinked.The outer sheath at the gas section was inspected and the inner sheath was found misaligned with the outer sheath.Also, the gas ramp was found lifted.No other issues with the stent and delivery system were noted.The reported event of stent premature deployment could not be not confirmed as this failure occurred during the procedure and could not be functionally/visually verified.It is most likely that procedural factors encountered during the procedure limited the performance of the device.Handling and manipulation of the device during procedure could have caused the observed damages of the device.However, there is no indication of what the customer reported because the stent was returned completely deployed and the reported event could not be functionally/visually verified.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.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 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: 13191663
• Report Number: 3005099803-2021-08161
• Device Sequence Number: 11863176
• Product Code: FGE
• UDI-Device Identifier: 08714729296898
• UDI-Public: 08714729296898
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012752
• 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,Followup
• Report Date (Section B): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2021
• Device Model Number: M00569690
• Device Catalogue Number: 6969
• Device Lot Number: 0025514855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 71 KG