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

Model Number	M001272610
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tear in the packaging occurred.A 10.3 flexima drainage catheter was used for percutaneous transhepatic biliary drainage (ptbd) in the gallbladder.During unpacking, it was observed that there was a tear in the packaging from the top part and the drainage catheter was out from the torn part.The device was no longer sterile; therefore, it was not used.The procedure was completed using another device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The flexima was not returned for analysis; however, photos were attached in the parent record, and it was observed that the device was inside the package, and the package was damaged.
Event or Problem Description
It was reported that a tear in the packaging occurred.A 10.3 flexima drainage catheter was used for percutaneous transhepatic biliary drainage (ptbd) in the gallbladder.During unpacking, it was observed that there was a tear in the packaging from the top part and the drainage catheter was out from the torn part.The device was no longer sterile; therefore, it was not used.The procedure was completed using another device.There were no patient complications as a result of this event.

• 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: 21711001
• Report Number: 2124215-2025-17350
• Device Sequence Number: 19968399
• Product Code: FGE
• UDI-Device Identifier: 08714729454960
• UDI-Public: (01)08714729454960(17)250606(10)29542137
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 05/22/2025

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: 06/06/2025
• Device Model Number: M001272610
• Device Catalogue Number: M001272610
• Device Lot Number: 0029542137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/22/2025
• Date Device Manufactured: 06/07/2022
• 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
• Patient Sex: Unknown