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

Model Number	20233
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 10mmx60mm wallflex biliary transhepatic stent was advanced for treatment.However, during deployment, it was noted that the valve body and exterior tube were separated.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.A 10mmx60mm wallflex biliary transhepatic stent was advanced for treatment.However, during deployment, it was noted that the valve body and exterior tube were separated.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the shaft separation occurred 1 cm from the hub outside the patient.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The stent was returned fully covered and undeployed.The outer light blue sheath was returned detached form the valve body (handle break).No more damages were found in the device.
Event or Problem Description
It was reported that shaft break occurred.A 10mmx60mm wallflex biliary transhepatic stent was advanced for treatment.However, during deployment, it was noted that the valve body and exterior tube were separated.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the shaft separation occurred 1 cm from the hub outside the patient.

• Brand Name: WALLFLEX BILIARY TRANSHEPATIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10455453
• Report Number: 2134265-2020-11421
• Device Sequence Number: 19714018
• Product Code: FGE
• UDI-Device Identifier: 08714729820512
• UDI-Public: 08714729820512
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K112543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2022
• Device Model Number: 20233
• Device Catalogue Number: 20233
• Device Lot Number: 0025151886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 08/25/2020; 09/09/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/01/2020; 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR