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

Model Number	30935
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter hub came off.A 10 flexima apdl was placed on (b)(6) 2019 and on (b)(6) 2019 the hub on the flexima drainage catheter detached.The drainage catheter was replaced.No patient complications were reported.
Event or Problem Description
It was reported that the catheter hub came off.A 10 flexima apdl was placed on (b)(6) 2019 and on (b)(6) 2019 the hub on the flexima drainage catheter detached.The drainage catheter was replaced.No patient complications were reported.It was further reported that the flexima was not placed in the chest.
Event or Problem Description
It was reported that the catheter hub came off.A 10 flexima apdl was placed on (b)(6) 2019 and on (b)(6) 2019 the hub on the flexima drainage catheter detached.The drainage catheter was replaced.No patient complications were reported.It was further reported that the flexima was not placed in the chest.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Product analysis was performed as per procedure (usdc product analysis guidelines) ad.The catheter returned has the hub detached; moreover, the flare of the extrusion was found formed, it is evidence that the manufacturing process was properly performed.The catheter returned detached/cut at 11 cm from the flare end.The rest of the catheter (the hub section) was not returned for analysis.Additionally, the shaft was received with a suture knob and residues were noted along the device.

• 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: 9157580
• Report Number: 2134265-2019-11990
• Device Sequence Number: 2838022
• Product Code: FFA
• UDI-Device Identifier: 08714729323112
• UDI-Public: 08714729323112
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup,Followup
• Report Date (Section B): 11/18/2019

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 Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0023914972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 10/06/2019; 10/28/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/24/2019; 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1