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

Model Number	M00569660
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device 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 rx uncovered stent was to be used to treat a malignant stricture in the 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 dilated prior to stent placement.According to the complainant, during the procedure, the physician was unable to deploy the stent at first.When the physician removed the device, suddenly the stent deployed above the stricture.The physician was not able to remove the stent using forceps, basket, or other gi accessories.On (b)(6) 2019, the patient underwent choledochojejunostomy and the stent was removed during the procedure.The patient's condition at the conclusion of the procedure was reported to be stable and was hospitalized due to the surgery.The stent expired on (b)(6) 2019, however the physician decided to use it at his own discretion.

• Brand Name: WALLSTENT RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8932782
• Report Number: 3005099803-2019-04180
• Device Sequence Number: 11314258
• Product Code: FGE
• UDI-Device Identifier: 08714729296867
• UDI-Public: 08714729296867
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K012752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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: 07/06/2019
• Device Model Number: M00569660
• Device Catalogue Number: 6966
• Device Lot Number: 0021575126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 60