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

Model Number	30975
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the string is about to rip or has pulled away.An 8 flexima apdl drainage catheter was selected for use.During preparation, it appears that the string is about to rip or has pulled away at the loop where the string is.Consequently, they did not use this particular catheter on the patient.They used another one, with the same batch number which appeared to be fine and completed the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The catheter was returned for this complaint, with its flexible cannula loaded.The suture was inspected, and no damages were observed.No damages were observed to the returned device.The flexible cannula was loaded and unloaded without problems.No issues were identified during the product analysis.
Event or Problem Description
It was reported that the string is about to rip or has pulled away.An 8 flexima apdl drainage catheter was selected for use.During preparation, it appears that the string is about to rip or has pulled away at the loop where the string is.Consequently, they did not use this particular catheter on the patient.They used another one, with the same batch number which appeared to be fine and completed the procedure.There were no patient complications reported.

• Brand Name: FLEXIMA APDL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15880172
• Report Number: 2124215-2022-48415
• Device Sequence Number: 2468555
• Product Code: FFA
• UDI-Device Identifier: 08714729191759
• UDI-Public: 08714729191759
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

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: 04/21/2025
• Device Model Number: 30975
• Device Catalogue Number: 30975
• Device Lot Number: 0029270681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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