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

Model Number	31175
Medical Device Problem Codes	Collapse (1099); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip detachment and retrieved device component occurred.The drainage catheter was attached to the patient's kidneys.A 8/25 flexima apdl was selected for use.The flexima apdl catheter was advanced over the wire.The catheter was meeting resistance in the retroperitoneal soft tissues and the tip was telescoping.The physician pulled the catheter back and noticed that the clear tapered piece at the tip was missing.This piece was seen on the catheter while it was loaded on the wire.It was concluded that the piece somehow detached from the catheter inside the patient.The detached catheter tip could not be located within the patient.Consequently, the physician dissected the soft tissues in attempt to located the detached tip.Locating the detached tip was unsuccessful.It was noted that the detached catheter tip was still on the wire about 4-5 cm deep to the skin and the physician believes this likely pushed the part through the kidney and into the collecting system.The procedure was completed with a non boston scientific device.No further patient complications were reported.

• Brand Name: FLEXIMA APDL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11517099
• Report Number: 2134265-2021-03330
• Device Sequence Number: 3827762
• Product Code: FFA
• UDI-Device Identifier: 08714729191780
• UDI-Public: 08714729191780
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• 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: 07/13/2023
• Device Model Number: 31175
• Device Catalogue Number: 31175
• Device Lot Number: 0025707087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2021
• 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: Other; Required Intervention