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

Model Number	M00545590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(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 the procedure.The exact date of the event was not reported nor the procedure name.According to the complainant, during the procedure, when attempted to release the stent, the guide catheter broke inside the patient and the stent deployed prematurely.The broken device was removed along with the stent using a snare or forceps.The procedure was completed with another flexima rx biliary stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during the procedure.The exact date of the event was not reported nor the procedure name.According to the complainant, during the procedure, when attempted to release the stent, the guide catheter broke inside the patient and the stent deployed prematurely.The broken device was removed along with the stent using a snare or forceps.The procedure was completed with another flexima rx biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
B3: date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.F10: problem code 1069 captures the reportable event of guide catheter broke.H11: correction to block e1: initial reporter address: (b)(6).Block h10: a visual evaluation of the returned device found that the pull wire was completely retracted and it was kinked in several locations.The push catheter was kinked in several locations.The guide catheter was detached from the delivery system and it was not returned for analysis, the reported issue of stent premature deployment could not be functionally/visually verified, however, guide catheter detachment can cause both components fall off from the delivery system; consequently, confirming the reported complaint.Based on the product analysis, most likely that procedural or anatomical factors encountered during 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 the push catheter and pull wire, once the device is kinked in several locations the device become difficult to retract the guide catheter; continued attempts to retract the guide catheter in order to release the stent can result in guide catheter/stent detachment.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A dhr (device history record) review was performed and no deviation was found.

• 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: 8372017
• Report Number: 3005099803-2019-00849
• Device Sequence Number: 1333013
• Product Code: FGE
• UDI-Device Identifier: 08714729337898
• UDI-Public: 08714729337898
• 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): 04/11/2019

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: 10/11/2020
• Device Model Number: M00545590
• Device Catalogue Number: 4559
• Device Lot Number: 21247994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/11/2019
• 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