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

Model Number	32337
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: used (b)(6) 2023.As the event date was not reported.
Event or Problem Description
It was reported that the device was contaminated.A flexima drainage catheter was selected for use.During preparation, a tear in the package was noted, and sterility of the device was compromised.As per lab manager, the damage must have been due to shipping.As it was damaged upon arrival.There was no patient involvement.
Event or Problem Description
It was reported that the device was contaminated.A flexima drainage catheter was selected for use.During preparation, a tear in the package was noted and sterility of the device was compromised.As per lab manager, the damage must have been damaged due to shipping as it was damaged upon arrival.There was no patient involvement.
Additional Manufacturer Narrative
B3 - date of event: used 05/01/2023 as the event date was not reported.The device was not returned; nevertheless, the costumer provides one photo of the device inside the pouch.The photo provided shows that the pouch device was observed with a damage created by cut in the frontal section.Additionally, it was observed that the pouch information matches with the complaint information.

• 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: 17063344
• Report Number: 2124215-2023-28257
• Device Sequence Number: 12294591
• Product Code: FGE
• UDI-Device Identifier: 08714729454984
• UDI-Public: 08714729454984
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 11/22/2025
• Device Model Number: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0030592102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• 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