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

Model Number	30815
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drain was difficult to remove.A 6f flexima apd drainage catheter system was selected for use in a procedure.Drainage could not be performed with this device.The drain had coiled at the distal end of the drain into three spirals.This coiling made withdrawal difficult, which possibly caused bleeding.No further patient complications were reported.

• Brand Name: FLEXIMA APD
• 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: 13971325
• Report Number: 2134265-2022-03721
• Device Sequence Number: 6581220
• Product Code: FFA
• UDI-Device Identifier: 08714729323051
• UDI-Public: 08714729323051
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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: 05/18/2024
• Device Model Number: 30815
• Device Catalogue Number: 30815
• Device Lot Number: 0027342247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown