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

Model Number	M00570520
Medical Device Problem Codes	Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch 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 2cm malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tight and was not dilated prior to the stent placement.According to the complainant, during procedure, the stent was able to be deployed but in an incorrect location.The stent was repositioned by pulling the retrieval loop with a rat tooth grasping forceps.However, it was reported that the physician might have pulled only one retrieval loop which resulted to malformation/ unraveling of the stent retrieval loop.The stent was removed and another wallflex biliary stent was placed to complete the procedure.There were no patient complications reported as a result of this event.
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 2cm malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tight and was not dilated prior to the stent placement.According to the complainant, during procedure, the stent was able to be deployed but in an incorrect location.The stent was repositioned by pulling the retrieval loop with a rat tooth grasping forceps.However, it was reported that the physician might have pulled only one retrieval loop which resulted to malformation/ unraveling of the stent retrieval loop.The stent was removed and another wallflex biliary stent was placed to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code (b)(4).Problem code (b)(4).A deployed wallflex biliary stent was received for analysis; the delivery system was not returned.Visual examination identified no issue with the stent.The stent was measured to be within specifications.The reported event that the stent unraveled could not be confirmed.Reportedly, the complainant may have grasped the stent by only one retrieval loop.This may have resulted in the perception that the stent was unraveling, but the stent was not damaged.The investigation concluded that the device may have encountered difficult patient anatomies such as stenosis or tortuosity during the procedure which limited the performance of the device.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the labeled indication.The dfu states, "the wallflex biliary rx fully covered stent should not be moved or removed after completion of the initial stent placement procedure.Manipulating, repositioning or removal of the stent may result in perforation, bleeding, tissue abrasion or other patient injury." as per available information, the stent was fully deployed from the delivery system when it was repositioned.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.

• 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: 7932144
• Report Number: 3005099803-2018-60585
• Device Sequence Number: 1998559
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: 08714729764908
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 11/16/2018

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: 02/27/2018
• Device Model Number: M00570520
• Device Catalogue Number: 56427
• Device Lot Number: 0018974678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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