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

Model Number 30935

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

Implant date - implant date: implant date of the drainage catheter was not known and estimated to (b)(6) 2022.

Event Description

It was reported that the string snapped and remained in the patient.An 8/apdl flexima regular drainage catheter had been implanted on a prior date.During removal of the flexima, the drainage catheter was removed easily.The previously implanted flexima drainage catheter was easily removed.However, while attempting to remove the string, there was significant resistance.It was thought that the suture had become embodied with fibrous tissue.A significant length of the string was removed despite the difficult but then snapped under tension.The residual length of the sting was left within the renal and perirenal tissues.

• Brand Name: FLEXIMA APDL
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15983135
• MDR Text Key: 305490754
• Report Number: 2124215-2022-49994
• Device Sequence Number: 1
• Product Code: FFA
• UDI-Device Identifier: 08714729323105
• UDI-Public: 08714729323105
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0029694019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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