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	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's facility name: (b)(6).(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 a bile duct drainage in the bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, outside the patient, when the physician tried to deploy the stent, the guide catheter became separated at the proximal portion.No part of the device fell off inside the patient.The procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter's facility name: (b)(6) hospital.Block h6: device code 1048 captures the reportable event of guide catheter broke.Block h10: the returned flexima rx biliary stent was analyzed and a visual evaluation noted that only the detached portion of the guide catheter was returned, it was observed to have kinks in the middle section of the guide catheter.The stent was not returned for analysis, which indicates that the stent was deployed during procedure; consequently, not confirming the reported complaint of stent failure to deploy, therefore, it was concluded that the investigation conclusion code of this event will be documented as no problem detected since the device complaint or problem could not be confirmed.The reported event of guide catheter break was confirmed.It is possible that operational factors, such as user technique/handling during procedure contributed to the observed kinks in the guide catheter.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 can result in guide catheter detachment issue.Therefore, the most probable root cause 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 a bile duct drainage in the bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, outside the patient, when the physician tried to deploy the stent, the guide catheter became separated at the proximal portion.No part of the device fell off inside the patient.The procedure was successfuly completed with another flexima biliary stent.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: 9806118
• Report Number: 3005099803-2020-00730
• Device Sequence Number: 18996099
• 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): 04/27/2020

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: 10/20/2022
• Device Model Number: M00545560
• Device Catalogue Number: 4556
• Device Lot Number: 0024629251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1