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

Model Number	M00539210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the insertion, when the physician unpacked the stent, it was noticed that the leading barb would not open, therefore it is not possible for a stent implantation.The procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.Investigation results revealed that the guide catheter was detached/separated, therefore this event has been deemed an mdr reportable event.Please see for full investigation details.
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).(b)(4).The returned flexima biliary stents (stent and delivery system) was returned, the stent was returned loaded in the delivery system indicating a failure to deploy it.The guide catheter broken at proximal section, broken section was not returned.The push catheter was kinked/bent in several locations and also it was buckled at proximal section.The suture hole was torn.A microscope inspection was performed and found that the suture hole was torn.The stent was carefully inspected and no damages or /irregular shapes were identified on the stent and stent barbs.No other problem with the device were noted.The reported event of the leading barbs were not opened was not confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.After analysis, it was observed no visual issues were identified on the stent and stent barbs.The stent was carefully inspected under magnification and no damages or /irregular shapes were identified on the stent and stent barbs.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 kink/bend of the push catheter, user technique when the device was removed from its package or advancing the device through the scope could kink the push catheter, this condition can cause friction between the components at kinked/bent areas.Also, a force applied in retracting the guide catheter in order to release the stent could buckle the push catheter and continued attempts to release the stent could result in guide catheter breakage.Additionally, the suture hole torn indicates that the suture was submitted to tension forces resulting in tearing the suture hole.Therefore, the most probable cause of those failures is adverse event related to procedure since it is the most likely that the adverse event occurred during the preparation and the device had no influence on event.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15434129
• Report Number: 3005099803-2022-05074
• Device Sequence Number: 20334966
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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: 01/18/2025
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0028706799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 09/15/2022
• Date Device Manufactured: 01/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown