MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 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	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Date of event was approximated to (b)(6) 2020 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 a flexima rx biliary stent was used during bile duct drainage in the bile duct performed.The exact event date was not reported.According to the complainant, during the procedure, when they tried to release the stent, the proximal part of the guide catheter outside of the patient had broken.The broken guide catheter remained within the push catheter, enabling the delivery system to be removed in one piece and no part of the device fell inside the patient.The procedure was successfully completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) initial reporter state/province: (b)(6) block b3: date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Block h6: device code 1069 captures the reportable event of guide catheter break.Block h10: product analysis the returned flexima rx biliary stents was analyzed.The visual evaluation noted that the guide catheter was found detached and it was not returned for analysis.It was observed kinks in the push catheter.The stent was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.It is possible that operational factors, such as user technique/handling during procedure contributed to the observed kinks to along the device.This device condition can cause resistance at the moment to retract the pull wire/guide catheter, continued attempts to retract the pull wire/guide catheter in order to release the stent or force applied to retract pull wire/guide catheter in addition to the device kinks can result in guide catheter detachment, this device condition can lead to the reported stent difficult to deploy issue.Therefore the most probable root cause for this event is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during bile duct drainage in the bile duct performed.The exact event date was not reported.According to the complainant, during the procedure, when they tried to release the stent, the proximal part of the guide catheter outside of the patient had broken.The broken guide catheter remained within the push catheter, enabling the delivery system to be removed in one piece and no part of the device fell inside the patient.The procedure was successfully completed with this device.There were no patient complications reported as a result of this event.

• 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: 9732605
• Report Number: 3005099803-2020-00500
• Device Sequence Number: 18914616
• Product Code: FGE
• UDI-Device Identifier: 08714729337867
• UDI-Public: 08714729337867
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: 10/13/2022
• Device Model Number: M00545560
• Device Catalogue Number: 4556
• Device Lot Number: 0024590305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1