MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ADVANIX¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00532210
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The reported event of "stent kinked." 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 corporation that an advanix¿ biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2016.According to the complainant, during the procedure, the advanix¿ biliary stent kinked while inserting it in to common bile duct.The physician was unable to place the stent in the lesion.The procedure was completed with another advanix¿ biliary stent.The patient's condition at the conclusion of the procedure was reported to be "good.".

• Brand Name: ADVANIX¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6227061
• Report Number: 3005099803-2016-03998
• Device Sequence Number: 13660798
• Product Code: FGE
• UDI-Device Identifier: 08714729786993
• UDI-Public: (01)08714729786993(17)20170531(10)18011777
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K101786
• 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): 12/12/2016

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: 05/31/2017
• Device Model Number: M00532210
• Device Catalogue Number: 3221
• Device Lot Number: 18011777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 01/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR