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

Model Number	M00570540
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary covered stent was to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent did not expand.The stent was removed from the patient using forceps, and the procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6: imdrf device code a150101 captures the reportable event of stent failure to expand.
Additional Manufacturer Narrative
Blocks b5 and h6 were updated based on the additional information received on march 17, 2024.Block h11: a wallflex biliary stent was received for analysis.Visual examination of the returned device found the stent fully covered and undeployed.The stainless-steel handle was bent.Functional inspection was performed by manually gripping the outer sheath and pulling the tip distally to deploy the stent.The stent was expanded correctly.No other problems were noted to the stent and delivery system.According to information received from the complainant on march 17, 2024, confirming that the device was bent, and the stent could not be deployed.This event is no longer considered an mdr reportable event.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary covered stent was to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent did not expand.The stent was removed from the patient using forceps, and the procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.Additional information received on may 17, 2024: it was reported that the device was bent, and the stent could not be deployed.

• 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: 18912963
• Report Number: 3005099803-2024-01003
• Device Sequence Number: 20555983
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: 10/26/2024
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0030430695
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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 Sex: Unknown