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	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.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 that a wallflex biliary stent was to be implanted in the in the common bile duct to treat malignant stenosis during a stenting procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was able to be deployed; however, it moved out of the intended location.The stent was removed from the patient with forceps, and the procedure was completed with another wallflex biliary 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.
Additional Manufacturer Narrative
Block h6: problem code 3009 captures the reportable event of stent positioning problem.Block h10: the returned hot axios delivery system was analyzed, and a visual evaluation noted that the stent was not returned.The outer blue sheath was returned kinked.A functional evaluation could not be performed because the stent was deployed.No other issues with the device were noted.The reported event of stent positioning issue could not be confirmed because this event occurred during the procedure and it is not possible to replicate the event in the laboratory.It was confirmed that the outer blue sheath was kinked.Most likely, factors encountered during the procedure and/or the interaction with the scope could have caused the kink in the outer sheath and the patient's anatomy could be the cause of the stent positioning issue.Therefore, a review and analysis of all available information indicated that the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted in the in the common bile duct to treat malignant stenosis during a stenting procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the stent was able to be deployed; however, it moved out of the intended location.The stent was removed from the patient with forceps, and the procedure was completed with another wallflex biliary 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
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9825490
• Report Number: 3005099803-2020-00781
• Device Sequence Number: 3069436
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 04/17/2021
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0023666200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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: 44 YR
• Patient Weight: 60