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

Model Number	32615
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radiopaque marker detached.A vtc/8/k flexima regular was selected for use.During procedure, the radiopaque marker became detached.There were no patient complications reported and the patient's condition was stable.
Event or Problem Description
It was reported that the radiopaque marker detached.A vtc/8/k flexima regular was selected for use.During procedure, the radiopaque marker became detached.There were no patient complications reported and the patient's condition was stable.It was further reported that the radiopaque marker was removed from the catheter.The catheter was completely removed from the body of the patient and no device fragments were left inside.

• Brand Name: FLEXIMA
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8919075
• Report Number: 2134265-2019-10026
• Device Sequence Number: 514063
• Product Code: GBO
• UDI-Device Identifier: 08714729323372
• UDI-Public: 08714729323372
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 03/04/2022
• Device Model Number: 32615
• Device Catalogue Number: 32615
• Device Lot Number: 0023427950
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR