MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION APDL; CATHETER, BILIARY, DIAGNOSTIC

Model Number	33775
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was noted that the drain broke inside the patient.The target lesion was located in the pleural cavity.A flexima all purpose drainage was selected for use.The drain was place in chest tube thoracostomy post triple bypass.The pneumothorax resolved over the next few days and the device was removed without any issue.However, the patient complained that a lot of force was done to remove the device.A follow up chest x-ray was performed, and it was noted that the tip of the apdl lodged in the pleural cavity.A video-assisted thoracoscopic surgery was done to remove the fragment.The patient's well and no complications were reported.

• Brand Name: APDL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 13543778
• Report Number: 2134265-2022-00816
• Device Sequence Number: 14420071
• Product Code: FGE
• UDI-Device Identifier: 08714729115243
• UDI-Public: 08714729115243
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2022

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: 10/12/2024
• Device Model Number: 33775
• Device Catalogue Number: 33775
• Device Lot Number: 0028196169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown