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

Model Number	M00570530
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf impact code f2301 captures the reportable event of adjusting the position using biopsy forceps.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary covered stent rmv was to be implanted in the bile duct to treat a malignant stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was attempted to be deployed.However, it was found that several stent wires were blocking the opening of the device, and stent wires were exposed to the drainage mouth.The position was adjusted using biopsy forceps, and the stent was removed from the patient partially deployed on the delivery system.Another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary covered stent rmv was to be implanted in the bile duct to treat a malignant stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was attempted to be deployed.However, it was found that several stent wires were blocking the opening of the device, and stent wires were exposed to the drainage mouth.The position was adjusted using biopsy forceps, and the stent was removed from the patient partially deployed on the delivery system.Another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf impact code f2301 captures the reportable event of adjusting the position using biopsy forceps.Block h10: a wallflex biliary stent was received for analysis.Visual examination of the returned device found the stent partially deployed.Functional examination was performed without problems as no resistance was felt.No other damages were noted with the stent and delivery system.Product analysis did not confirm the reported event of stent break; however, the analysis did confirm the reported stent partially deployed.Taking all available information into consideration, the investigation concluded that the reported event of stent partially deployed was likely due to procedural factors such as lesion characteristics, handling of the device, the technique used by the physician during the procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.

• 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: 18909273
• Report Number: 3005099803-2024-01026
• Device Sequence Number: 15143660
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: 08714729764915
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/02/2024

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: 03/22/2025
• Device Model Number: M00570530
• Device Catalogue Number: 7053
• Device Lot Number: 0031288928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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: 49 YR
• Patient Sex: Unknown
• Patient Weight: 83 KG