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

Model Number 31815

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2023

Event Type  Injury  

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 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
• 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.; 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
• MDR Text Key: 331105409
• Report Number: 2124215-2023-69731
• Device Sequence Number: 1
• Product Code: FFA
• UDI-Device Identifier: 08714729300694
• UDI-Public: 08714729300694
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31815
• Device Catalogue Number: 31815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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