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	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(4).The returned flexima biliary stent was analyzed, and a visual evaluation noted that the push catheter was found bent/kink in the proximal section,and the guide catheter was completely removed of the original position, also, it was found stretched and detached.The reported event was confirmed.Based on product analysis, it is possible that operational factors, such as user technique/handling during procedure contributed to the observed kink in the device.This device condition could cause resistance at the moment to retract the pull wire/guide catheter, continued attempts to retract the pull wire/guide catheter to release the stent or force applied to retract pull wire/guide catheter can result in guide catheter stretched and detachment due to friction between the components.Therefore, 'adverse event related to procedure' is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during a procedure.According to the complainant, the product presented defective.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.This event has been deemed a reportable event based on the investigation results; guide catheter break.

• 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: 9806381
• Report Number: 3005099803-2020-00774
• Device Sequence Number: 16304359
• Product Code: FGE
• UDI-Device Identifier: 08714729162599
• UDI-Public: 08714729162599
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: 01/18/2021
• Device Model Number: M00539280
• Device Catalogue Number: 3928
• Device Lot Number: 0021635858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/09/2020
• Patient Sequence Number: 1