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

Model Number	32337
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that the stiffening cannula has become lodged in the drain.A flexima drainage catheter was selected for use in the biliary tract.During the procedure, the drains had been flushed and soaked in saline prior to the loading of the stiffening cannula.However, it was noted that the stiffening cannula has become lodged in the drain, and it has not been able to be removed, necessitating the removal of the entire drain.The procedure was completed with a different device and no patient complications were reported.However, device analysis revealed that the distal tip of the stent was observed broken at the distal tip.
Additional Manufacturer Narrative
Date of event: used (b)(6) 2023 as the event date was not reported.Device evaluated by mfr: the complaint device was received for product analysis.The device was returned with the flexible cannula stuck inside.It was observed that the stent was kinked at the pigtail section.The cannula was observed kinked at proximal section and the distal tip of the stent was observed broken at the distal tip.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed on the device.Under the microscope the distal tip of the stent was observed broken at the distal tip.No other issues were identified during the product analysis.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16936050
• Report Number: 2124215-2023-21673
• Device Sequence Number: 5730952
• Product Code: FGE
• UDI-Device Identifier: 08714729454953
• UDI-Public: 08714729454953
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2023

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: 09/12/2025
• Device Model Number: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0030141021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRAINAGE CATHETER - COOK
• Patient Sex: Unknown