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

Model Number	M00545620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was approximately (b)(6) 2019 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and 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 an rx biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct.The exact event date was not provided.According to the complainant, during the procedure, when the guide catheter was advanced down the scope for stent deployment, they noticed when it reached to the ampulla, the guide catheter was broken.The procedure was completed with another rx biliary stent.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 fine.
Event or Problem Description
It was reported to boston scientific corporation that an rx biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct.The exact event date was not provided.According to the complainant, during the procedure, when the guide catheter was advanced down the scope for stent deployment, they noticed when it reached to the ampulla, the guide catheter was broken.The procedure was completed with another rx biliary stent.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 fine.
Additional Manufacturer Narrative
Date of event: date of event was approximately (b)(6) 2019 as no event date was reported.Problem code 1048 captures the reportable event of guide catheter broke.The device has not been received for analysis.Upon receipt and 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.Correction : product problem changed to adverse and product problem.Correction : updated to required intervention to prevent permanent impairment/damage.Correction : malfunction changed to serious injury.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8537056
• Report Number: 3005099803-2019-02023
• Device Sequence Number: 11377177
• Product Code: FGE
• UDI-Device Identifier: 08714729337928
• UDI-Public: 08714729337928
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/10/2019

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: 12/13/2021
• Device Model Number: M00545620
• Device Catalogue Number: 4562
• Device Lot Number: 0023085215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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