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

Model Number	20233
Medical Device Problem Codes	Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent had reconstrainment issues.The target lesion was located in the biliary vessel.A 10mmx60mm wallflex biliary transhepatic stent was advanced for treatment.However, during the procedure, it was noted that the device would not deploy correctly and the physician felt that it got caught up on outer sheath.The device was removed from the patient, but was removed without full reconstrainment.The stent was eventually deployed outside the patient.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device returned with its original pouch.The stent was received deployed and expanded.No other issues were identified during the product analysis.The stent was measured along the main body to confirm that was within specification.
Event or Problem Description
It was reported that stent had reconstrainment issues.The target lesion was located in the biliary vessel.A 10mm x 60mm wallflex biliary transhepatic stent was advanced for treatment.However, during the procedure, it was noted that the device would not deploy correctly and the physician felt that it got caught up on outer sheath.The device was removed from the patient, but was removed without full reconstrainment.The stent was eventually deployed outside the patient.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• 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: 8611691
• Report Number: 2134265-2019-05224
• Device Sequence Number: 13918347
• Product Code: FGE
• UDI-Device Identifier: 08714729820512
• UDI-Public: 08714729820512
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K112543
• 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): 05/29/2019

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: 01/20/2021
• Device Model Number: 20233
• Device Catalogue Number: 20233
• Device Lot Number: 0023220430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1