MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB; CATHETER, BILIARY, DIAGNOSTIC

Model Number	32900
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter hub was dislodge.An 8.3/25 expel drainage catheter was selected for use.It was inserted for a day and found to be not working well.Chest drainage was performed; however, it was noted that the hub was dislodged and the physician had to change it the next day.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the catheter hub was dislodge.An 8.3/25 expel drainage catheter was selected for use.It was inserted for a day and found to be not working well.Chest drainage was performed; however, it was noted that the hub was dislodged and the physician had to change it the next day.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the patient was able to recover and the catheter change was done on the same day.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the catheter was returned separated/cut at 21.5cm from the pigtail.The proximal section (hub section) of the catheter was not returned for analysis.
Event or Problem Description
It was reported that the catheter hub was dislodge.An 8.3/25 expel drainage catheter was selected for use.It was inserted for a day and found to be not working well.Chest drainage was performed; however, it was noted that the hub was dislodged and the physician had to change it the next day.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the patient was able to recover and the catheter change was done on the same day.

• Brand Name: EXPEL DRAINAGE CATHETER WITH TWIST-LOC HUB
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8367076
• Report Number: 2134265-2019-01665
• Device Sequence Number: 1915683
• Product Code: FGE
• UDI-Device Identifier: 08714729860587
• UDI-Public: 08714729860587
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K141335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2019

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: 08/29/2021
• Device Model Number: 32900
• Device Catalogue Number: 32900
• Device Lot Number: 22587348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 02/26/2019; 03/20/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/19/2019; 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1