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

Model Number	M00570500
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a4: patient's weight: 79.5 kilograms.Block e1 (initial reporter facility name): (b)(6).Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f2301 captures the additional device used to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx covered stent was to be implanted to treat a malignant biliary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent would not fully expand.The stent was removed from the patient with a foreign body device, and another wallflex biliary stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx covered stent was to be implanted to treat a malignant biliary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent would not fully expand.The stent was removed from the patient with a foreign body device, and another wallflex biliary stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Blocks e1 (initial reporter address 2 and initial reporter city), e3, e4 and h11 were corrected.Block a4: patient's weight: 79.5 kilograms.Block e1: initial reporter facility name: (b)(6) hospital; reported here as the facility name exceeded character limit for the designated field.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f2301 captures the additional device used to remove the stent.

• 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: 20353678
• Report Number: 3005099803-2024-04918
• Device Sequence Number: 6518115
• Product Code: FGE
• UDI-Device Identifier: 08714729764885
• UDI-Public: 08714729764885
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: 09/06/2024
• Device Model Number: M00570500
• Device Catalogue Number: 7050
• Device Lot Number: 0030103449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 09/07/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 80 KG