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

Model Number	32337
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties occurred resulting in increased pain.The patient was undergoing a bile duct drainage procedure.A 10f flexima drainage catheter was inserted.The inner cannula and the wire became stuck during removal.While attempting to remove the components, the catheter accordioned in the patient.The patient experienced increased pain which was managed with midazolam and fentanyl.Additionally, hematobilia was observed due to irritation of the bile duct.The issue occurred with two catheters.The device was able to be removed and the procedure was completed with another device.No further complications were reported.The patient is in good condition.
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was not returned by the customer.A photo of the pouch was received confirming device identification.A video taken during the procedure was provided.The reported resistance between the cannula and a drainage catheter was observed.However, the video could not confirm what wire or other devices were used during the procedure, whose interaction could affect the device performance.
Event or Problem Description
It was reported that removal difficulties occurred resulting in increased pain.The patient was undergoing a bile duct drainage procedure.A 10f flexima drainage catheter was inserted.The inner cannula and the wire became stuck during removal.While attempting to remove the components, the catheter accordioned in the patient.The patient experienced increased pain which was managed with midazolam and fentanyl.Additionally, hematobilia was observed due to irritation of the bile duct.The issue occurred with two catheters.The device was able to be removed and the procedure was completed with another device.No further complications were reported.The patient is in good condition.

• Brand Name: FLEXIMA
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17714320
• Report Number: 2124215-2023-46484
• Device Sequence Number: 2236050
• Product Code: FGE
• UDI-Device Identifier: 08714729454960
• UDI-Public: 08714729454960
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2026
• Device Model Number: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0031222127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown