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

Model Number	32900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date and implant date estimated as the first date of the month of the aware date, as no event date or implant date was reported.
Event or Problem Description
It was reported that the catheter broke down.An 8.3/25 expel drainage catheter with twist-loc hub was in a patient for about three weeks.It was then noted that the device looked like it broke down and rotted.No patient complications were reported.
Additional Manufacturer Narrative
Event date and implant date estimated as the first date of the month of the aware date, as no event date or implant date was reported.Device evaluated by the manufacturer: the device was returned for analysis.A visual inspection revealed that the device was returned with the shaft separated near to the bladder pigtail and with evidence of cracks along the device.It is important to mention the most distal section of he catheter was not returned for analysis.
Event or Problem Description
It was reported that the catheter broke down.An 8.3/25 expel drainage catheter with twist-loc hub was in a patient for about three weeks.It was then noted that the device looked like it broke down and rotted.No patient complications were reported.

• 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: 8716311
• Report Number: 2134265-2019-07195
• Device Sequence Number: 1845179
• Product Code: FGE
• UDI-Device Identifier: 08714729860587
• UDI-Public: 08714729860587
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: UZ
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 09/13/2021
• Device Model Number: 32900
• Device Catalogue Number: 32900
• Device Lot Number: 0022656460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1