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

Model Number	M00539270
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Stretched (1601); Defective Device (2588); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0401 captures the reportable investigation findings of catheter-guide break.Block h11: a flexima biliary preloaded stent was received for analysis.Visual inspection found that the guide catheter was detached, kinked, buckled/accordioned, and stretched.The guidewire was stuck inside the guide catheter.The push catheter was kinked, and the push catheter suture hole was torn.Media inspection of the photos provided also found that the guide catheter was kinked, buckled/accordioned, and a guidewire was stuck inside the guide catheter.No other problems were noted with the device.Product analysis confirmed the reported events of device guidewire stuck, stent difficult to deploy, and push catheter kinked; however, the reported events of stent kinked and push catheter buckled material were not confirmed.The guide catheter was most likely kinked, buckled/accordioned, stretched, and detached due to the force applied when it was felt that the stent could not be deployed.Additionally, this could have also occurred due to the instructions for use (ifu) not being followed or also due to the complications that appeared during the procedure which caused the guide catheter to be unable to handle the amount of pressure being used on it.If the device could not deploy the stent due to the guidewire not being retracted, there is a possibility that the same force applied when attempting to deploy the stent caused the push catheter suture hole to be torn and the suture to be detached.Lastly, the push catheter was likely kinked by the amount of force applied to deploy the stent.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was observed that the guidewire was stuck inside the guide catheter.However, the ifu states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used in the bile duct to treat gallstone pancreatitis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was positioned at the target site and the guide catheter was manipulated to the point of no return; however, it was noted that the guide catheter was bent, and the stent could not be deployed.Subsequently, the stent was removed using foreign body forceps which resulted in scraping and bleeding in the patient's gastrointestinal tract.The bleeding was resolved and did not require any additional intervention.Upon removal of the device, it was noted that the push catheter was wrinkled, the stent was kinked, and the guidewire became stuck in the guide catheter.The guidewire was eventually removed by slowly removing it from the guide catheter.The procedure was completed with another flexima biliary preloaded stent of a different size.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the guide catheter was detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block b5 has been corrected.Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0401 captures the reportable investigation findings of catheter-guide break.Block h11: a flexima biliary preloaded stent was received for analysis.Visual inspection found that the guide catheter was detached, kinked, buckled/accordioned, and stretched.The guidewire was stuck inside the guide catheter.The push catheter was kinked, and the push catheter suture hole was torn.Media inspection of the photos provided also found that the guide catheter was kinked, buckled/accordioned, and a guidewire was stuck inside the guide catheter.No other problems were noted with the device.Product analysis confirmed the reported events of device guidewire stuck, stent difficult to deploy, and push catheter kinked; however, the reported events of stent kinked and push catheter buckled material were not confirmed.The guide catheter was most likely kinked, buckled/accordioned, stretched, and detached due to the force applied when it was felt that the stent could not be deployed.Additionally, this could have also occurred due to the instructions for use (ifu) not being followed or also due to the complications that appeared during the procedure which caused the guide catheter to be unable to handle the amount of pressure being used on it.If the device could not deploy the stent due to the guidewire not being retracted, there is a possibility that the same force applied when attempting to deploy the stent caused the push catheter suture hole to be torn and the suture to be detached.Lastly, the push catheter was likely kinked by the amount of force applied to deploy the stent.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was observed that the guidewire was stuck inside the guide catheter.However, the ifu states, "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was used in the bile duct to treat gallstone pancreatitis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was positioned at the target site and the guide catheter was manipulated to the point of no return; however, it was noted that the guide catheter was bent, and the stent could not be deployed.Subsequently, the stent was removed using foreign body forceps which resulted in scraping and bleeding in the patient's gastrointestinal tract.The bleeding was resolved and did not require any additional intervention.Upon removal of the device, it was noted that the push catheter was wrinkled, the stent was kinked, and the guidewire became stuck in the guide catheter.The guidewire was eventually removed by slowly removing it from the guide catheter.The procedure was completed with another flexima biliary preloaded stent of a different size.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the guide catheter was detached.Update based on review on 24feb2025: the jagwire guidewire became stuck in the guide catheter and was unable to be removed.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21307527
• Report Number: 3005099803-2025-00285
• Device Sequence Number: 8083713
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: 08714729162582
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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 Model Number: M00539270
• Device Catalogue Number: M00539270
• Device Lot Number: 0034252517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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: Male