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

Model Number	M00570540
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 covered stent was to be used to treat a malignant stricture in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly the patient's anatomy was tight.According to the complainant, at the end of the stent placement procedure, angiography was performed and noticed that the stent moved out from the original location.The stent was removed with forceps.The procedure was completed with another wallflex biliary stent.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
(b)(4).Results: a fully deployed wallflex biliary stent was received for analysis; the delivery system was not returned.Visual analysis of the returned device found that no issues noted with the device.The patient's anatomy was reported to be tight, which may have contributed to the issue with stent positioning.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Additionally, "stent migration" and "stent misplacement" are noted within the dfu as potential adverse events associated with the use of this device.Therefore, the most probable root cause is known inherent risk of device.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex biliary rx covered stent was to be used to treat a malignant stricture in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly the patient's anatomy was tight.According to the complainant, at the end of the stent placement procedure, angiography was performed and noticed that the stent moved out from the original location.The stent was removed with forceps.The procedure was completed with another wallflex biliary stent.There were no patient complications 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: 7965770
• Report Number: 3005099803-2018-60848
• Device Sequence Number: 19259171
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/03/2018

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: 09/22/2019
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0021167828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/03/2018
• 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
• Patient Age: 60 YR
• Patient Weight: 150