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

Model Number	M00570740
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the wallflex biliary stent was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to one of two procedures involving one wallflex biliary stent.Refer to manufacturer report # 3005099803-2022-03912 and 3005099803-2022-03915 for the associated procedure information.It was reported to boston scientific corporation on july 05, 2022 that a wallflex biliary rx partially covered stent was to be implanted to treat a malignancy common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2022.During the first procedure (the subject of mfr.Report #3005099803-2022-03912), friction was met inside the scope and when the wallflex biliary stent was attempted to be used it was noted that there was no stent on the delivery system.The delivery system of the wallflex biliary stent was removed and the procedure was completed with another wallflex biliary stent without issue.However, after the scope was cleaned and attempted to be used in a second procedure (the subject of this report), friction was noted while advancing an unknown catheter device through the working channel of the scope.A metal wire of a stent was then noted at the tip of the scope.It was determined that the wallflex biliary stent noted inside the scope was the same wallflex biliary stent from the first procedure which had deployed prematurely inside the scope during the first procedure.The wallflex biliary stent was removed together with the scope and another wallflex biliary stent was used to complete the procedure there were no patient complications reported as a result of this event.

• 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: 15094527
• Report Number: 3005099803-2022-03915
• Device Sequence Number: 5320668
• Product Code: FGE
• UDI-Device Identifier: 08714729759331
• UDI-Public: 08714729759331
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 07/25/2022

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: 02/04/2024
• Device Model Number: M00570740
• Device Catalogue Number: 7074
• Device Lot Number: 0028812080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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