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

Model Number	H965431200
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted 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
It was reported to boston scientific corporation on (b)(6) 2019 that a wallstent biliary partially covered stent has been implanted to treat a 25mm pancreatic tumor in the mid common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement procedure.Reportedly, the patient's prognosis was bad and the patient cannot tolerate any intervention other than stent placement.According to the complainant, the guidewire was in placed and the stent was positioned at the middle of the stenosis.During the procedure, pressure was felt and the stent was unable to be deployed.Reportedly, the device was removed from the patient several times to check its functionality.The physician then reinserted the device to the patient and attempted to deploy the stent.Reportedly, the blue marker was positioned at the papilla and during stent deployment, resistance was felt while pulling the outer sheath around the stent.The plastic handle was detached from the blue outer sheath and the stent was deployed.However, it was noticed that 1cm of the stent was deployed outside the common bile duct, above the stenosis, and proximally towards the liver.Reportedly, the stent remains implanted.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.However, it was reported that the patient was in the icu due to health condition.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8748625
• Report Number: 3005099803-2019-03227
• Device Sequence Number: 16714446
• Product Code: FGE
• UDI-Device Identifier: 08714729229902
• UDI-Public: 08714729229902
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K000308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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: 08/26/2020
• Device Model Number: H965431200
• Device Catalogue Number: 3120
• Device Lot Number: 0022567049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 60