MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMWIRE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M00556161
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(impact codes): impact code f05 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
Note: this report pertains to two wallflex fully covered biliary stents and a dreamwire used in the same patient and procedure.It was reported to boston scientific corporation that the two wallflex fully covered biliary stents and a dreamwire were used in the common bile duct to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) with sphincterotomy, stone removal, and stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous.During the procedure, the first wallflex biliary stent (the subject of mfr.Report # 3005099803-2023-02837) was deployed; however, there was difficulty in removing the delivery system.Subsequently, the stent and the guidewire were removed along with the delivery system.A second wallflex biliary stent (the subject of this report) was deployed; however, the same problem occurred.Reportedly, the guidewire was kinked.The procedure was canceled and rescheduled on (b)(6) 2023 due to device availability.There were no patient complications reported as a result of this event.

• Brand Name: DREAMWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17026154
• Report Number: 3005099803-2023-02851
• Device Sequence Number: 15344908
• Product Code: EZB
• UDI-Device Identifier: 08714729777861
• UDI-Public: 08714729777861
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2025
• Device Model Number: M00556161
• Device Catalogue Number: 5616
• Device Lot Number: 0030572487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2022
• 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
• Patient Sex: Unknown