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

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987)

Event Date 02/06/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced hemorrhage, a ruptured lung and required additional intervention for treatment.A flexima all purpose drainage catheter was used in a patient who was ventilated and in critical care.When the drain was being removed, the staff member was unaware that the stent was locked, as it appeared to be a normal pigtail drain.After removal, the patient experienced a ruptured lung and major hemorrhage requiring five units of transfusion, inotropic support and was referred for consideration of thoracoscopy.A video-assisted thoracoscopic surgery (vat) was later performed with evacuation of up to two liters of blood clot.As a result of this, the patient had an increased stay in the critical care unit and remained there, from other issues, as well.

• 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; 2546 first street; propark, el coyol ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11942855
• MDR Text Key: 254484265
• Report Number: 2134265-2021-07246
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention