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

Model Number	56429
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Problem code 3270 captures the reportable event of stent failed to expand.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific on (b)(6) 2018 that a wallflex biliary rx uncovered stent was to be used during a procedure performed on (b)(6) 2018.According to the complainant, during procedure, the stent did not open; it remained closed and was impossible to place.The procedure was completed with another wallflex biliary stent.There were no patient complications as a result of this event.The patient condition following the procedure was reported to be stable.Boston scientific has been unable to obtain additional information and/ or specific information regarding the circumstances surrounding these events to date.Should additional relevant details become available a supplemental report will be submitted.

• 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: 7798890
• Report Number: 3005099803-2018-60077
• Device Sequence Number: 16466470
• Product Code: FGE
• UDI-Device Identifier: 08714729765332
• UDI-Public: 08714729765332
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 08/20/2018

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: 04/30/2020
• Device Model Number: 56429
• Device Catalogue Number: 56429
• Device Lot Number: 0022063693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/20/2018
• 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