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	06/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hub detached.A 12 flexima apdl catheter drainage was used in a right chest tube placement.It was noted that the hub detached as the white cuff pulled away from the blue shaft.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The catheter returned has the hub detached.The heat shrink was received detached from the hub.The catheter working length was observed cut/separated and the most proximal section (the flare section) was not returned for analysis.Residues were observed on the heat shrink and hub (evidence of use).
Event or Problem Description
It was reported that the hub detached.A 12 flexima apdl catheter drainage was used in a right chest tube placement.It was noted that the hub detached as the white cuff pulled away from the blue shaft.No patient complications were reported.

• 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: 8748486
• Report Number: 2134265-2019-07594
• Device Sequence Number: 11189567
• 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): 09/03/2019

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: 06/06/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR