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	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that the hub came apart.A 12fr flexima apdl drainage catheter was selected for use.During procedure, it was noted that the device came apart at the hub.The procedure was completed with another of the same device.No patient complications reported.
Event or Problem Description
It was reported that the hub came apart.A 12fr flexima apdl drainage catheter was selected for use.During procedure, it was noted that the device came apart at the hub.The procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.-device evaluated by manufacturer: the device was returned for analysis.The catheter returned has the hub detached off of the device.However, the heat shrink was received properly attached to the catheter and the flare of the device was found formed, which is evidence that the manufacturing process was properly performed.

• 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: 8784772
• Report Number: 2134265-2019-08108
• Device Sequence Number: 11189483
• Product Code: FFA
• UDI-Device Identifier: 08714729323143
• UDI-Public: 08714729323143
• 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
• Report Date (Section B): 08/26/2019

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: 04/09/2022
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0023626649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR