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 11/24/2023

Event Type  Injury  

Event Description

It was reported that the broken suture remained in the patient.The target lesion was located in the not tightly tortuous bile duct.A 7.3 flexima apdl all purpose drainage was selected for implant.During removal, first catheter was cut and pulled out.However, resistance was encountered when the suture was pulled out and it got separated, and remained inside the patient.The procedure was completed with this device.The patient was stable after the procedure; however, an adverse health effects was confirmed.

• 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.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18330795
• MDR Text Key: 330525405
• Report Number: 2124215-2023-68109
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 11/24/2023
• 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
• Treatment: GUIDEWIRE-ACCESSORY DEVICE
• Patient Outcome(s): Other