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	02/25/2019
Type of Reportable Event	Malfunction
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 was used during an endoscopic retrograde cholangiopancreatography procedure performed in the common bile duct on (b)(6) 2019.According to the complainant, during the procedure, when the stent was being released, the guide catheter was broken.The broken guide catheter remained within the push catheter, enabling the delivery system to be removed in one piece.However, the stent was deployed successfully.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block h6: device code 1069 captures the reportable event of guide catheter broke.Block h10: the device was received and analysis is completed.A visual evaluation of the returned device found that the proximal section of the pull wire was kinked in several locations.The push catheter was severely kinked in some locations.The guide catheter was detached from the delivery system and it was not returned with the device.Based on the product analysis, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Patient anatomy and customer maneuvering during the use of the device can lead to kink push catheter.Once the push catheter is kinked in several locations, this condition can cause resistance at the moment to retract the pull wire/guide catheter which can lead to issues deploying the stent, continued attempts to deploy the stent or force applied retracting the pull wire in order to release the stent can result in guide catheter detachment due to friction between the components (catheters/pull wire) at kinked areas.Therefore the most probable root cause for this event is adverse event related to procedure.A review of the device history record (dhr) was performed, no anomalies were noted found.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure performed in the common bile duct on (b)(6) 2019.According to the complainant, during the procedure, when the stent was being released, the guide catheter was broken.The broken guide catheter remained within the push catheter, enabling the delivery system to be removed in one piece.However, the stent was deployed successfully.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be fine.

• 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: 8445653
• Report Number: 3005099803-2019-01350
• Device Sequence Number: 2887905
• 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): 04/22/2019

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: 12/13/2021
• Device Model Number: M00545620
• Device Catalogue Number: 4562
• Device Lot Number: 0023085215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1