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

Model Number	32337
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stylet was difficult to removed and was broke.A flexima catheter drainage was selected for use.During the procedure, the inner stylet would not come out after placing the biliary drain, furthermore, it got broke into pieces as the physician had to use force to pull out the plastic stylet and to deploy the pigtail.All the broken pieces were removed but the procedure was prolonged for additional of 2 hours.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The stent, the flexible cannula and an accessory were returned.The pouch was returned, and it was observed that the pouch information matches with the complaint information.Visual inspection revealed that the stent was kinked at the middle section and the flexible cannula was detached.No other issues were observed in the devices.Under the microscope it was observed that the flexible cannula was detached.
Event or Problem Description
It was reported that the stylet was difficult to removed and was broke.A flexima catheter drainage was selected for use.During the procedure, the inner stylet would not come out after placing the biliary drain, furthermore, it got broke into pieces as the physician had to use force to pull out the plastic stylet and to deploy the pigtail.All the broken pieces were removed but the procedure was prolonged for additional of 2 hours.The procedure was completed with a different device.No patient complications were reported.

• 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: 17686315
• Report Number: 2124215-2023-44731
• Device Sequence Number: 2634453
• Product Code: FGE
• UDI-Device Identifier: 08714729454953
• UDI-Public: 08714729454953
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: 04/20/2024
• Device Model Number: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0027180543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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 Sex: Unknown