MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	31535
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contamination occurred.A flexima apdl was selected for use in a bile duct.Upon opening the outer box, the packaging of the device was damaged and leaking gas, which was not completely sealed.It was suspected that there were bacteria.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that contamination occurred.A flexima apdl was selected for use in a bile duct.Upon opening the outer box, the packaging of the device was damaged and leaking gas, which was not completely sealed.It was suspected that there were bacteria.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: the drainage catheter system kit was returned for the analysis.It was possible to observe that the flexible cannula and the suture were bent.No damages were observed in the other sections returned.The complaint was not confirmed for an unsealed packaging issue because the packaging was not returned for analysis.

• Brand Name: FLEXIMA APDL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• 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: 20433500
• Report Number: 2124215-2024-62247
• Device Sequence Number: 7860880
• Product Code: FFA
• UDI-Device Identifier: 08714729323471
• UDI-Public: 08714729323471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944290
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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 Expiration Date: 09/28/2026
• Device Model Number: 31535
• Device Catalogue Number: 31535
• Device Lot Number: 0032533508
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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: Female