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

Model Number	M00569620
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial reporter's facility name is (b)(6) hospital.Imdrf patient code e2401 captures the reportable event of injury to the biliary vessel.Imdrf impact code f2303 captures the administration of painkillers.Imdrf device code a041001 captures the reportable event of stent wire punctured sheath.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be implanted in the bile duct to treat a biliary stricture during a stent placement procedure performed on (b)(6), 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, resistance was felt during delivery and the patient experienced pain.The device was then removed, and it was noted that the stent wire punctured the tip part of the outer sheath causing injury to the patient's biliary vessel.The patient was administered with painkillers and the procedure was completed with a different device.The patient's condition following the procedure was reported to be stable.Note: it was reported that the wallflex biliary uncovered stent was to be implanted to treat a benign stenosis.However, per the wallstent rx biliary, with or without permalume covering instructions for use (ifu), the stent is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.The device is not indicated for the treatment of benign stenosis.Photos of the complaint device were provided showing the stent's wire punctured the outer sheath.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be implanted in the bile duct to treat a biliary stricture during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, resistance was felt during delivery and the patient experienced pain.The device was then removed, and it was noted that the stent wire punctured the tip part of the outer sheath causing injury to the patient's biliary vessel.The patient was administered with painkillers and the procedure was completed with a different device.The patient's condition following the procedure was reported to be stable.Note: it was reported that the wallflex biliary uncovered stent was to be implanted to treat a benign stenosis.However, per the wallstent rx biliary, with or without permalume covering instructions for use (ifu), the stent is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.The device is not indicated for the treatment of benign stenosis.Photos of the complaint device were provided showing the stent's wire punctured the outer sheath.
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name is (b)(6).Block h6: imdrf patient code e2401 captures the reportable event of injury to the biliary vessel.Imdrf impact code f2303 captures the administration of painkillers.Imdrf device code a041001 captures the reportable event of stent wire punctured sheath.Block h11: a wallstent biliary rx uncovered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection of the device in the scope found the outer clear sheath punctured.Furthermore, a photo of the device was provided, and it was observed that the wire of the stent punctured the outer clear sheath.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of stent wire punctured sheath.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.The complainant reported that the wallflex biliary uncovered stent was to be implanted to treat a benign stenosis.The ifu states, "the stent is indicated for use in the treatment of biliary strictures produced by malignant neoplasms." it is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted in the reported 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.

• 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: 19153620
• Report Number: 3005099803-2024-01754
• Device Sequence Number: 12873174
• Product Code: FGE
• UDI-Device Identifier: 08714729296829
• UDI-Public: 08714729296829
• 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): Unknown
• 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): 06/10/2024

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: 03/19/2025
• Device Model Number: M00569620
• Device Catalogue Number: 6962
• Device Lot Number: 0032452027
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG