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

Model Number	30935
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on additional information received on 03nov2021.It was reported that the device stuck inside the patient and broke when pulled out.Two flexima apdl were selected for use.During the procedure, resistance was encountered in removing the devices as it got stuck inside the patient.Subsequently, the devices were removed by pulling it with a strong force which was hard enough that it broke apart and the plastic stiffener came apart inside the catheter.The procedure was completed with another of the same device.There were no complications reported and patient was fine.
Additional Manufacturer Narrative
H6.Component codes and evaluation result codes were updated.Device evaluated by manufacturer: the device was returned for analysis.The device was found with the shaft middle and proximal section detached/separated.The catheter shows evidence of cut at sections detached.The distal section was not returned with the device.Additionally the device was received with an unknown device loaded and section of flexible cannula accordioned and detached at the same point where the catheter was cut.
Event or Problem Description
Reportable based on additional information received on (b)(6) 2021.It was reported that the device stuck inside the patient and broke when pulled out.Two flexima apdl were selected for use.During the procedure, resistance was encountered in removing the devices as it got stuck inside the patient.Subsequently, the devices were removed by pulling it with a strong force which was hard enough that it broke apart and the plastic stiffener came apart inside the catheter.The procedure was completed with another of the same device.There were no complications reported and patient was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was found with the shaft middle and proximal section detached/separated.The catheter shows evidence of cut at sections detached.The distal section was not returned with the device.Additionally the device was received with an unknown device loaded and section of flexible cannula accordioned and detached at the same point where the catheter was cut.
Event or Problem Description
Reportable based on additional information received on 03nov2021.It was reported that the device stuck inside the patient and broke when pulled out.Two flexima apdl were selected for use.During the procedure, resistance was encountered in removing the devices as it got stuck inside the patient.Subsequently, the devices were removed by pulling it with a strong force which was hard enough that it broke apart and the plastic stiffener came apart inside the catheter.The procedure was completed with another of the same device.There were no complications reported and patient was fine.

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12773598
• Report Number: 2134265-2021-13958
• Device Sequence Number: 17540199
• Product Code: FFA
• UDI-Device Identifier: 08714729323105
• UDI-Public: 08714729323105
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2024
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0027694721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 12/06/2021; 12/06/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/16/2021; 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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
• Patient Sex: Unknown