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

Model Number 30815

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter: risk manager.

Event Description

It was reported via facility medwatch (b)(4) that the tube was dislodged and separated.A flexima apd was selected for use and placed as a chest tube.However, it was noted that the chest tube was disconnected and was clamped.X-ray was immediately done and showed that the tube was dislodged.The chest tube was removed in interventional radiology later same day.The tube was examined, and it was pulled apart from where it was attached to the hub, and was separated at the connection of the distal lower lumbar back.The glue holding the tubing on the hub did not hold.Additional intervention was required, and the device was successfully removed over a wire under fluoroscopy.There were no complications reported, and the patient was stable post device removal.

• Brand Name: FLEXIMA APD
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11515844
• MDR Text Key: 240641869
• Report Number: 2134265-2021-03027
• Device Sequence Number: 1
• Product Code: FFA
• UDI-Device Identifier: 08714729323129
• UDI-Public: 08714729323129
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: 30815
• Device Catalogue Number: 30815
• Device Lot Number: 0026500980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 97