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

Model Number	H965430600
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be file.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallstent biliary uncovered stent was to be implanted to treat an obstructive jaundice-hilar cholangiocarcinoma in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortous and was dilated prior to stent placement.During the procedure, the stent was successfully deployed inside the patient.However, during removal of the delivery system, the stent got caught on the delivery system.The stent was removed together with the delivery system.The procedure was completed with another wallstent biliary stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• Brand Name: WALLSTENT 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: 12891978
• Report Number: 3005099803-2021-06187
• Device Sequence Number: 17234500
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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: 08/27/2023
• Device Model Number: H965430600
• Device Catalogue Number: 3060
• Device Lot Number: 0027920059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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