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

Model Number	M00539200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima¿ biliary stent was used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in common bile duct on (b)(6) 2017 according to the complainant, during attempted deployment of the flexima¿ biliary stent, the guide catheter stretched and broke.This event reportedly required intervention to remove the broken device, however, no further information could be obtained at this time.After manipulation of the device, the stent was successfully deployed and the procedure was completed using this device.This event did not result in any complication or harm to the patient.The patient's condition at the conclusion of the procedure was reported to be "stable." attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: FLEXIMA¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6536754
• Report Number: 3005099803-2017-01294
• Device Sequence Number: 11095444
• Product Code: FGE
• UDI-Device Identifier: 08714729337362
• UDI-Public: (01)08714729337362(17)20171130(10)17465275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: M00539200
• Device Catalogue Number: 3920
• Device Lot Number: 17465275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/02/2017
• 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
• Patient Age: 86 YR
• Patient Weight: 45