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

Model Number 32375

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem Internal Organ Perforation (1987)

Event Date 06/23/2023

Event Type  Injury  

Event Description

It was reported that patient injury occurred.An 8.3 flexima drainage catheter was selected for right nephrostomy placement in the kidney.During the procedure, it was noted that the renal collecting system was ruptured due to inability to feed off catheter from metal stiffener.The patient has fully recovered.

Manufacturer Narrative

Device evaluated by mfr: the stent was returned with the metal cannula for the analysis.Visual inspection was performed, and it was revealed that the hub and the suture were in good conditions.The metal cannula was kinked.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more issues were observed in the devices.

Event Description

It was reported that patient injury occurred.An 8.3 flexima drainage catheter was selected for right nephrostomy placement in the kidney.During the procedure, it was noted that the renal collecting system was ruptured due to inability to feed off catheter from metal stiffener.The patient has fully recovered.

• Brand Name: FLEXIMA
• Type of Device: 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.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17418984
• MDR Text Key: 320028377
• Report Number: 2124215-2023-37473
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 08714729323303
• UDI-Public: 08714729323303
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

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
• Device Operator: Health Professional
• Device Model Number: 32375
• Device Catalogue Number: 32375
• Device Lot Number: 0031102171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other