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

Model Number	M00545590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent as used during an endoscopic retrograde cholangiopancreotography (ercp) procedure in the sphincter of oddi performed on (b)(6) 2017.According to the complainant, during procedure, when attempted to place the flexima rx biliary stent, the guide catheter completely broke off inside the patient and separated from the delivery system.The broken piece of guide catheter was removed with biopsy forceps.However the procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "stable".
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent as used during an endoscopic retrograde cholangiopancreotography (ercp) procedure in the sphincter of oddi performed on (b)(6) 2017.According to the complainant, during procedure, when attempted to place the flexima rx biliary stent, the guide catheter completely broke off inside the patient and separated from the delivery system.The broken piece of guide catheter was removed with biopsy forceps.However the procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "stable.".
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the pull wire is completely retracted and the proximal section of the pull wire is curved (bent) in the middle.The push catheter is bent in several locations.The guide catheter is detached, most proximal section is tapered indicating that it was properly attached to the pull wire during manufacturing and it is kinked in several locations.Based on the product analysis, most likely some procedural/anatomical factors were encountered during the procedure could have affected the device performance and its integrity.Most likely, the catheters and pull wire were kinked/bent due to some handling aspect of the device possibly manipulation of the device during procedure.With the catheters bound by kinks or bends there will be difficulty to retract the pull wire and if it is forcibly pulled, most likely that the guide catheter is going to be detached from the delivery system.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A dhr (device history record) review was performed and no deviation was found.Labeling review was performed and no anomalies were found. .

• 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: 7175527
• Report Number: 3005099803-2018-00020
• Device Sequence Number: 1447700
• Product Code: FGE
• UDI-Device Identifier: 08714729337898
• UDI-Public: 08714729337898
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 12/20/2017

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: 03/31/2018
• Device Model Number: M00545590
• Device Catalogue Number: 4559
• Device Lot Number: 17771089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 02/12/2018
• 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
• Patient Age: 76 YR
• Patient Weight: 77