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

Model Number	31535
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.A flexima apdl catheter was selected for use in an emergency case, in which the patient was already in bad condition.During the procedure, after the pigtail catheter was inserted into the patient, the physician wanted to connect the catheter to the collection bag, but the luer lock was loose and could not be connected.A 30mm syringe was used instead to collect the fluid and the procedure was completed with a different device.Two days after the procedure date, the patient died while the catheter was still inside the patient's body.No action was taken to treat the event and the primary cause of death is unknown.It is unknown if an autopsy was performed.
Additional Manufacturer Narrative
Device evaluated by mfr: only the connecting tube was returned for analysis.During product analysis, it was noted that no issues or defects were in the device returned.The catheter was not returned for analysis.A photo was attached at the complaint record.It was possible to observe only the connecting tube and no damages or visual defects were noted.No other devices were observed in the photo attached.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the patient died.A flexima apdl catheter was selected for use in an emergency case, in which the patient was already in bad condition.During the procedure, after the pigtail catheter was inserted into the patient, the physician wanted to connect the catheter to the collection bag, but the luer lock was loose and could not be connected.A 30mm syringe was used instead to collect the fluid and the procedure was completed with a different device.Two days after the procedure date, the patient died while the catheter was still inside the patient's body.No action was taken to treat the event and the primary cause of death is unknown.It is unknown if an autopsy was performed.

• Brand Name: FLEXIMA APDL
• Common Device Name: 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15148833
• Report Number: 2124215-2022-24519
• Device Sequence Number: 5671065
• Product Code: FFA
• UDI-Device Identifier: 08714729323471
• UDI-Public: 08714729323471
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 01/14/2025
• Device Model Number: 31535
• Device Catalogue Number: 31535
• Device Lot Number: 0028687815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2022
• 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: Death
• Patient Sex: Unknown