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

Model Number	M00570740
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx partially covered stent was to be implanted in the common bile duct to treat cholangiocarcinoma during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2024.During the procedure, the stent could not be returned before the marker reached the non-return point.The doctor deployed the stent and then removed it from the patient.Another stent of different size was used to complete the procedure.There were no patient complications reported as a result of this event and the patients status was stable.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block e1: the initial reporter facility address is (b)(6).Block h6: imdrf device code captures the reportable event of stent positioning issue.
Additional Manufacturer Narrative
Blocks b5, e1 (initial reporter's address) have been updated with the additional information received on may 20, 2024.Block h6: imdrf device code captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx partially covered stent was to be implanted in the common bile duct to treat cholangiocarcinoma during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2024.During the procedure, the stent could not be returned before the marker reached the non-return point.The doctor deployed the stent and then removed it from the patient.Another stent of different size was used to complete the procedure.There were no patient complications reported as a result of this event.Additional information received on may 20, 2024: it was reported that the size of the lesion was 6mm and lesion was malignant.The patient's anatomy was not tortuous and was not dilated prior to stent placement.The stent was removed from the patient with forceps.
Additional Manufacturer Narrative
Block h6: imdrf device code captures the reportable event of stent positioning issue.Block h11: a wallflex biliary stent and delivery system were received for analysis.Visual inspection found the stent was fully deployed and expanded.No other damages were noted to the stent and delivery system.Product analysis could not confirm the reported event of stent positioning issue as this event occurred during the procedure, and it is not possible to replicate in the laboratory of analysis.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, stent positioning issue is noted within the ifu as a potential complication associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx partially covered stent was to be implanted in the common bile duct to treat cholangiocarcinoma during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2024.During the procedure, the stent could not be returned before the marker reached the non-return point.The doctor deployed the stent and then removed it from the patient.Another stent of different size was used to complete the procedure.There were no patient complications reported as a result of this event.Additional information received on may 20, 2024.It was reported that the size of the lesion was 6mm and lesion was malignant.The patient's anatomy was not tortuous and was not dilated prior to stent placement.The stent was removed from the patient with forceps.

• 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: 19366981
• Report Number: 3005099803-2024-02280
• Device Sequence Number: 6415076
• Product Code: FGE
• UDI-Device Identifier: 08714729759331
• UDI-Public: 08714729759331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

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: 09/28/2025
• Device Model Number: M00570740
• Device Catalogue Number: 7074
• Device Lot Number: 0032529849
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 05/20/2024; 07/09/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/15/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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: 73 YR
• Patient Sex: Female