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

Model Number	M00539220
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned flexima biliary stent was analyzed, and a visual evaluation noted that the stent was returned unloaded from the delivery system.The guide catheter was completely removed from the push catheter when received and it was kinked/bent in several locations, also it was stretched and broken.The broken section of guide catheter was not returned.The push catheter was kinked/bent at distal section and also it was buckled at proximal section.The suture was detached and it was not returned for analysis, the suture hole was torn, based on the findings from the analysis of the device, it is most likely that there were issues to deploy the stent during procedure.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, it s 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 the catheters, user technique when the device is removed from its package or advancing the device through the scope can kink the catheters, this condition can cause friction between the components at kinked/bent areas in the catheters, force retracting the guide catheter in order to release the stent can buckle the push catheter and continued attempts to release the stent can result in guide catheter stretching and breaking, additionally suture hole torn indicates that the suture was submitted to tension forces resulting in tearing the suture hole and breaking the suture from the delivery system.According to procedure, during manufacturing, the tip of guide catheter with guidewire is inserted into touhy-borst connector, then the guide catheter is advanced until hub and connector are flush, also it is confirmed kinks are not present using caution while advancing guide catheter.Additionally, during manufacturing it is confirmed that the suture is not twisted in tray, these steps of the process would have detected the observed damages on the device.Therefore, adverse event related to procedure is selected as the most probable root cause of the event.
Event or Problem Description
It was reported to boston scientific corporation that a fleximabiliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, the stent failed to deploy.Another flexima biliary stent was opened and successfully completed the procedure.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 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
• 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: 15444745
• Report Number: 3005099803-2022-05132
• Device Sequence Number: 15335985
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: 08714729162537
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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: 08/08/2024
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0027804777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 63 KG