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

Model Number	M00570650
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was implanted in the common bile duct on an unknown date.On an unknown date, post stent placement, it was noticed that the stent was embedded with tissue ingrowth.The wallflex biliary uncovered stent was attempted to be removed via duodenoscope; however, the stent could not be removed.The wallflex biliary uncovered stent remains in place, and another stent was implanted stent-in-stent to complete the procedure.There were no patient complications reported as a result of this event, and the patient is now doing well.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0106 captures the reportable event of stent obstruction within the device.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f2202 captures the endoscopic duodenoscopy procedure performed to remove the stent.Imdrf impact code f2301 captures the additional stent implanted on the patient.
Additional Manufacturer Narrative
Blocks b5 and h6 (device codes) have been updated based on the additional information received on november 9, 2023.Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0106 captures the reportable event of stent obstruction within the device.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f2202 captures the endoscopic duodenoscopy procedure performed to remove the stent.Imdrf impact code f2301 captures the additional stent implanted on the patient.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was implanted in the common bile duct on an unknown date.On an unknown date, post stent placement, it was noticed that the stent was embedded with tissue ingrowth.The wallflex biliary uncovered stent was attempted to be removed via duodenoscope; however, the stent could not be removed.The wallflex biliary uncovered stent remains in place, and another stent was implanted stent-in-stent to complete the procedure.There were no patient complications reported as a result of this event, and the patient is now doing well.It was reported that the stent was attempted to be removed because an uncovered biliary stent was implanted in error; the stent was supposed to be a covered stent, and there was no malignancy in the intended anatomy location.The stent has been successfully removed from the patient.Note: it was reported that the wallflex biliary rx uncovered stent was to be implanted in an anatomy location with no malignancy.Per the instructions for use (ifu), "the wallflex biliary rx uncovered stent system is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery." the stent is not indicated in an anatomy location with no malignancy.

• 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: 18065392
• Report Number: 3005099803-2023-05907
• Device Sequence Number: 15393386
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: 08714729758150
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140630
• 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,Followup
• Report Date (Section B): 12/04/2023

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 Model Number: M00570650
• Device Catalogue Number: 7065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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