MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570740
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex biliary rx partially covered stent was to be used to treat an obstruction in the common bile duct due to a mass in the head of the pancreas during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, during the removal of the delivery system, the distal tip of the catheter was caught on the stent and could not be removed without pulling the stent out from the patient.The physician removed the stent and delivery system with forceps, and the procedure was completed with another wallflex biliary rx stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7341698
• Report Number: 3005099803-2018-00571
• Device Sequence Number: 1103350
• Product Code: FGE
• UDI-Device Identifier: 08714729759331
• UDI-Public: 08714729759331
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2018

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: 07/20/2019
• Device Model Number: M00570740
• Device Catalogue Number: 7074
• Device Lot Number: 20910657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/15/2018
• 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