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

Model Number	M00569710
Medical Device Problem Codes	Positioning Failure (1158); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallstent biliary partially covered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection found the wires of the stent punctured the outer sheath.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received.A media inspection was performed of a photo provided by the complainant and it was also observed that the stent was fully covered and undeployed.No other issues were noted to the stent and delivery system.The reported event of stent failed to deploy was confirmed as the stent was received fully covered by the outer sheath and the functional evaluation revealed the stent was unable to be deployed.The investigation concluded that the reported event may likely be due to factors encountered during the procedure.It may be that the interaction of the device with the scope, the patient's anatomy, excessive force applied during attempted depoyment, and/or the physician reconstraining the stent and attempting to deploy it again could have contributed to stent failure to deploy and the observed event of stent wire punctured sheath.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.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on that a wallstent biliary rx partially covered stent was to be implanted to treat a 4cm cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to deploy partially and was recaptured to change position.When the stent was deployed again, resistance occured and the stent failed to deploy.Reportedly, the stent was fully covered by the outer sheath on the delivery system when it was removed from the patient.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.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent wire punctured the clear outer sheath.

• Brand Name: WALLSTENT RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11236190
• Report Number: 3005099803-2021-00226
• Device Sequence Number: 19793897
• Product Code: FGE
• UDI-Device Identifier: 08714729296911
• UDI-Public: 08714729296911
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K012752
• 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
• Report Date (Section B): 01/27/2021

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: 12/16/2021
• Device Model Number: M00569710
• Device Catalogue Number: 6971
• Device Lot Number: 0025607735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR