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

Model Number	1094-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the suture remained in the patient.A flexima ureteral stent system was inserted for drainage of the ureter.During removal of the device, at the end of the procedure, the locking suture could not be removed.The suture was cut at the string entry point and remained in the patient.
Additional Manufacturer Narrative
H6 - impact codes: corrected from 'insufficient information' to 'serious injury/illness/impairment'.
Event or Problem Description
It was reported that the suture remained in the patient.A flexima ureteral stent system was inserted for drainage of the ureter.During removal of the device, at the end of the procedure, the locking suture could not be removed.The suture was cut at the string entry point and remained in the patient.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis was completed.Visual analysis revealed that only the proximal section of the suture string was returned for analysis.The suture string was separated from the device.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No other issues were observed in the device.
Event or Problem Description
It was reported that the suture remained in the patient.A flexima ureteral stent system was inserted for drainage of the ureter.During removal of the device, at the end of the procedure, the locking suture could not be removed.The suture was cut at the string entry point and remained in the patient.

• Brand Name: FLEXIMA
• 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: 18334429
• Report Number: 2124215-2023-69872
• Device Sequence Number: 6739749
• Product Code: FAD
• UDI-Device Identifier: 08714729323778
• UDI-Public: 08714729323778
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

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 Expiration Date: 07/06/2025
• Device Model Number: 1094-01
• Device Catalogue Number: 1094-01
• Device Lot Number: 0029724493
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 02/05/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/04/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown