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

Model Number	M00570730
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to report the suspect device lot number; therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device 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 the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2019-03505 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2019 that two wallflex biliary rx partially covered stents were to be used to treat a pancreatic head mass which blocked the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tight and was dilated prior to stent placement procedure.According to the complainant, during the procedure, both wallflex bilary stents were able to be deployed.However, after the delivery systems were removed, the stents migrated out of the common bile duct.Both stents were removed with forceps and the procedure was completed with a plastic stent.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
• MDR Report Key: 8805100
• Report Number: 3005099803-2019-03506
• Device Sequence Number: 13534938
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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 Model Number: M00570730
• Device Catalogue Number: 7073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/18/2019
• 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: Required Intervention