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	04/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The returned flexima biliary stent was analyzed, and a visual evaluation noted that the one portion of the guide catheter at the proximal section was returned detached and stretched, the guide catheter was not returned for analysis.Additionally, the push catheter and the guide catheter were bent/ kinked in several locations.The suture was detached from the delivery system and it was not returned for analysis, also the suture hole in the push catheter was found torn.The stent was not returned for analysis, therefore, the reported failures of stent kinked and stent material deformation cannot be confirmed.No other issues with the device were noted.The reported event of stent kinked an deformed were not confirmed, however the guide catheter at the proximal section was returned detached.Based on the product analysis, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use in addition to continued attempts to retract the guide catheter or force applied to the device in order to release the stent can lead to the push catheter kink and guide catheter kinks, stretched, and detached.Additionally, the suture under tensile force during the procedure due to the kink/ bent section could result in the tearing of the suture hole and the encountered suture detached issue.The continued handling/ manipulation or force applied to the device in addition to the found device condition could result in the found issues.Therefore the most probable root cause for this event is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.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 a flexima biliary stent was used a during biliary stent implantation in the common bile duct perfomed on (b)(6) 2020.According to the complainant, during the procedure, the physician noticed that the stent was kinked and deformed inside the patient's body.The procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the guide catheter was detached/ separated, therefore this event has been deemed an mdr reportable event.

• 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: 10135828
• Report Number: 3005099803-2020-02220
• Device Sequence Number: 11668269
• Product Code: FGE
• UDI-Device Identifier: 08714729162599
• UDI-Public: 08714729162599
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 06/09/2020

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: 11/25/2021
• Device Model Number: M00539280
• Device Catalogue Number: 3928
• Device Lot Number: 0022985765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 56