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

Model Number	30935
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: patient is quite elderly, like (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The catheter separated/cut at the proximal section, however, no other defects were noted.
Event or Problem Description
Reportable based on device analysis completed on 15jun2019.It was reported that the drainage bag cannot be secured.A flexima apdl drainage catheter was selected for use.During the procedure, it was noted that the drain would not secure to the drainage bags and was then pulled up.The procedure was not completed due to the issue and the patient went back in for different procedure and place different drains.No complications reported and patient is fine.However, device analysis revealed catheter separated/cut at the proximal section.

• 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: 8771936
• Report Number: 2134265-2019-07903
• Device Sequence Number: 16561081
• Product Code: FFA
• UDI-Device Identifier: 08714729323112
• UDI-Public: 08714729323112
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

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: 01/31/2022
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0023258723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2019
• Initial Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1