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

Model Number	M00570740
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of inner sheath detachment.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex biliary rx partially covered stent was to be implanted in the sphincter of oddi to treat a malignant stenosis due to a tumor during a procedure performed on (b)(6) 2023.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, the wallflex biliary stent was successfully deployed; however, resistance was felt during removal of the delivery system.The physician applied force to remove the delivery system and a part of the yellow inner sheath was detached, and the implanted wallflex biliary partially covered stent moved out of the correct position.The detached inner sheath and the stent were removed from the patient using forceps, and another wallflex biliary stent was implanted to complete the procedure.There were no reported patient complications as a result of this event.Note: photos of the complaint device were provided by the complainant and showed the yellow inner sheath was detached and kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of inner sheath detachment.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf device code a1502 captures the reportable event of stent positioning issue.Block h10: the wallflex biliary delivery system was received for analysis.The stent was not received for analysis.Visual inspection of the returned device found that the inner sheath was detached, and the outer clear sheath was kinked.Media inspection was performed and found that the inner sheath was kinked and detached from the catheter.No more damages were noted on the delivery system.Product analysis confirmed the reported malfunctions of inner sheath detachment and inner sheath kinked.However, the reported malfunctions of delivery system difficult to remove, and stent positioning issue was not confirmed.The investigation concluded that procedural factors such as lesion characteristics, handling of the device, and the technique used could have resulted in inner sheath detachment and kinked inner sheath.Furthermore, the reported event of delivery system difficult to remove was not confirmed because this event happened during the procedure, and it was not possible to replicate it in the laboratory for analysis.Additionally, stent positioning issue was documented in the labeling as a potential complication as a result of the use of the device.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation on may 10, 2023, that a wallflex biliary rx partially covered stent was to be implanted in the sphincter of oddi to treat a malignant stenosis due to a tumor during a procedure performed on (b)(6) 2023.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, the wallflex biliary stent was successfully deployed; however, resistance was felt during removal of the delivery system.The physician applied force to remove the delivery system and a part of the yellow inner sheath was detached, and the implanted wallflex biliary partially covered stent moved out of the correct position.The detached inner sheath and the stent were removed from the patient using forceps, and another wallflex biliary stent was implanted to complete the procedure.There were no reported patient complications as a result of this event.Note: photos of the complaint device were provided by the complainant and showed the yellow inner sheath was detached and kinked.

• 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: 17032965
• Report Number: 3005099803-2023-02856
• Device Sequence Number: 17740754
• Product Code: FGE
• UDI-Device Identifier: 08714729759331
• UDI-Public: 08714729759331
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 07/26/2023

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 Expiration Date: 09/01/2024
• Device Model Number: M00570740
• Device Catalogue Number: 7074
• Device Lot Number: 0030077539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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: 45 YR
• Patient Sex: Male
• Patient Race: White