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

Model Number	31815
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 - date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.
Event or Problem Description
It was reported that the suture was implanted.A 7.3 fr flexima all purpose drainage catheter with lock was selected for use.During device removal, a resistance was felt when the remaining suture was retrieved.There was a concern that this would damage the organs by pulling out the device by force.The suture was cut out and the remaining part was implanted subcutaneously.The procedure was completed, and there were no patient complications reported.

• 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 DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18372698
• Report Number: 2124215-2023-69731
• Device Sequence Number: 12704452
• Product Code: FFA
• UDI-Device Identifier: 08714729300694
• UDI-Public: 08714729300694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 31815
• Device Catalogue Number: 31815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown