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

Model Number	30815
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter: risk manager.
Event or Problem 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
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11515844
• Report Number: 2134265-2021-03027
• Device Sequence Number: 19884807
• Product Code: FFA
• UDI-Device Identifier: 08714729323129
• UDI-Public: 08714729323129
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 97