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	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter break occurred.The target lesion was located in the vessel of the liver.The patient was brought in for a drain exchange of a previously implanted flexima drainage catheter from 2 week earlier.However, it was noted that the drain had broken near the hub.The broken flexima drainage catheter was successfully exchanged for a new device, same model.No patient complications were reported.
Event or Problem Description
It was reported that a catheter break occurred.The target lesion was located in the vessel of the liver.The patient was brought in for a drain exchange of a previously implanted flexima drainage catheter from 2 week earlier.However, it was noted that the drain had broken near the hub.The broken flexima drainage catheter was successfully exchanged for a new device, same model.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent was returned for the analysis.It is possible to observed that the device was detached, moreover the suture was detached.Based on analysis of the returned product, the reported allegation can be confirmed, due to the found issue during 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19619488
• Report Number: 2124215-2024-37786
• Device Sequence Number: 6954879
• Product Code: FGE
• UDI-Device Identifier: 08714729454977
• UDI-Public: 08714729454977
• 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): 08/15/2024

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: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0033387576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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: Unknown