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

Model Number	M00570660
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary uncovered stent was implanted in the bile duct to treat a malignant long stricture between the left intrahepatic duct and the common hepatic duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was able to be deployed; however, the delivery system could not be removed.They attempted to resheath the stent but was unable to proceed past halfway up the duct.Subsequently, the delivery system was cut using a rat-tooth forceps from inside the patient while a standard scissor was used from the outside of the biopsy cap.The stent remained implanted along with a portion of the inner sheath.Another wallflex biliary uncovered stent was implanted stent-in-stent to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX 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: 19533458
• Report Number: 3005099803-2024-02849
• Device Sequence Number: 20759238
• Product Code: FGE
• UDI-Device Identifier: 08714729759287
• UDI-Public: 08714729759287
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/13/2024

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: 01/24/2026
• Device Model Number: M00570660
• Device Catalogue Number: 7066
• Device Lot Number: 0033286012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/13/2024
• Date Device Manufactured: 01/25/2024
• 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 Sex: Unknown