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

Model Number	M00545560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 flexima rx biliary stent was used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in common bile duct on (b)(6) 2016.According to the complainant, upon deploying the stent, an area broke between the two catheters and the delivery system.The clear guide catheter stayed inside of the stent, and both the stent and broken catheter had to be removed with a snare.Another guidewire was manipulated within the duct, and then another stent was opened and placed to complete the procedure.This process took a total of 20 additional minutes which required the patient to be under anesthesia longer.No patient issues were reported as a result of this event.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6287521
• Report Number: 3005099803-2017-00078
• Device Sequence Number: 1002258
• Product Code: FGE
• UDI-Device Identifier: 08714729337867
• UDI-Public: (01)08714729337867(17)20190930(10)19763675
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K965147
• 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
• Report Date (Section B): 01/04/2017

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: 09/30/2019
• Device Model Number: M00545560
• Device Catalogue Number: 4556
• Device Lot Number: 19763675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/30/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention