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

Model Number	M00539280
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2019
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 biliary stent was used during a biliary stenting procedure in the biliary ducts performed on (b)(6) 2019.According to the complainant, during the procedure, the guide catheter broke into two pieces when the physician was deploying the stent and retracting the guide catheter.After releasing the stent, the inner guide catheter stopped moving smoothly in retracting, and it elongated until it broke.There were no patient complications reported as a result of this event.The patient's condition was stable.Attempts to obtain further information regarding retrieval of the broken guide catheter have been unsuccessful to date.If any additional relevant information is reported, a supplemental report will be submitted.
Additional Manufacturer Narrative
Block f10: problem code 1069 captures the reportable event of guide catheter broken.Block h10: a visual evaluation of the returned flexima biliary stent was performed.The guide catheter was observed stretched and detached in the proximal section, no other visual issues were found to along of the device.Tthe stent did not present any visual issue and it was loaded in the delivery system.Based on the product analysis, it is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to guide catheter found broken and stretched, the continued attempts to retract the guide catheter or force applied to the device in order to release the stent can result in guide catheter broken and stretching.Therefore the most probable root cause for this event is 'adverse event related to procedure' since the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed, no anomalies were observed, the review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during a biliary stenting procedure in the biliary ducts performed on (b)(6) 2019.According to the complainant, during the procedure, the guide catheter broke into two pieces when the physician was deploying the stent and retracting the guide catheter.After releasing the stent, the inner guide catheter stopped moving smoothly in retracting, and it elongated until it broke.There were no patient complications reported as a result of this event.The patient's condition was stable.Attempts to obtain further information regarding retrieval of the broken guide catheter have been unsuccessful to date.If any additional relevant information is reported, a supplemental report will be submitted.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8927779
• Report Number: 3005099803-2019-04235
• Device Sequence Number: 253485
• Product Code: FGE
• UDI-Device Identifier: 08714729162599
• UDI-Public: 08714729162599
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• 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): 09/30/2019

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: 03/10/2022
• Device Model Number: M00539280
• Device Catalogue Number: 3928
• Device Lot Number: 0023465360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1