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

Model Number	M00570520
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(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 september 18, 2019 that a wallflex biliary rx fully covered stent was to be used to treat a 2-3 cm stricture caused by choledochal tumor in the common bile duct during a biliay stent placement procedure performed on (b)(6) 2019.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 moved out of its position after deployment.The stent was removed with forceps and another wallflex biliary stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter's address 1: (b)(6).Block h6: problem code 3009 captures the reportable event of stent positioning problem.Block h10: a fully deployed wallflex biliary rx covered stent and delivery system were returned for analysis.Visual examination of the returned device found the outer sheath was kinked at the end of the stiffening mandrel.The inner member and clear outer sheath were also kinked at the guidewire access sheath (gas) section.The stent was measured to be within specifications.No other issues with the stent and delivery system were noted.The damages noted to the delivery system may have been a result of device manipulation post procedure outside the patient.Taking all available information into consideration, the investigation concluded that the reported event is likely due to procedural factors such as handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is adverse event related to the procedure.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 september 18, 2019 that a wallflex biliary rx fully covered stent was to be used to treat a 2-3 cm stricture caused by choledochal tumor in the common bile duct during a biliay stent placement procedure performed on (b)(6) 2019.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 moved out of its position after deployment.The stent was removed with forceps and another wallflex biliary stent was used to complete the procedure.There were no patient complications 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
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9180045
• Report Number: 3005099803-2019-04953
• Device Sequence Number: 2568784
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: 08714729764908
• 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): 12/12/2019

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: 06/24/2020
• Device Model Number: M00570520
• Device Catalogue Number: 7052
• Device Lot Number: 0022298822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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
• Patient Age: 80 YR
• Patient Weight: 52