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

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/13/2019

Event Type  Injury  

Event Description

It was reported that the device thread was left inside of the patient.A 8f flexima apdl catheter was selected for a patient procedure.The device was placed within the lower abdomen next to the colon ascendences on (b)(6) 2019 to release purulent drainage from the area.Two days later the physician performed a procedure to remove the device.While removing the drainage catheter, part of the suture remained in the patient.The physician is not blaming the drainage catheter for this event as he believes that this occurred due to an endoscopy clip that had been previously placed incorrectly.The sharp edges of the clip may have cut the thread off of the drainage catheter.The physician tried to catch the thread manually but it slipped into the patient.The drainage was removed by cutting the proximal end.The release of the pigtail configuration worked as it should and the drainage was removed.The physician left the thread in the patient and does not intend to remove it as the physician would like to avoid surgery.The procedure was completed with this device.No further patient complications were reported.

Event Description

It was reported that the device thread was left inside of the patient.A 8f flexima apdl catheter was selected for a patient procedure.The device was placed within the lower abdomen next to the colon ascendences on (b)(6) 2019 to release purulent drainage from the area.Two days later the physician performed a procedure to remove the device.While removing the drainage catheter, part of the suture remained in the patient.The physician is not blaming the drainage catheter for this event as he believes that this occurred due to an endoscopy clip that had been previously placed incorrectly.The sharp edges of the clip may have cut the thread off of the drainage catheter.The physician tried to catch the thread manually but it slipped into the patient.The drainage was removed by cutting the proximal end.The release of the pigtail configuration worked as it should and the drainage was removed.The physician left the thread in the patient and does not intend to remove it as the physician would like to avoid surgery.The procedure was completed with this device.No further patient complications were reported.It was further reported that the drainage catheter was originally placed to release pus (purulent drainage).There have been no complications recognized by the physicians due to the thread.The physician monitored it visually and by blood sample parameters.

• Brand Name: FLEXIMA APDL
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8799582
• MDR Text Key: 151343757
• Report Number: 2134265-2019-08246
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other