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	08/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drainage was separated into multiple pieces.The target lesion was located in the peri pancreatic area.A 10.3/25 expel drainage catheter was selected for use.During procedure, it was noted that the device was separated into multiple pieces after three weeks.The device was removed and replaced with another of the same expel drainage catheter to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The unit returned has catheter damaged, as part of overall visual revision.The device was returned in three separate sections with evidence of cracks along the device and pigtail, also, the device has a section damage with a knob, no other damages or anomalies were noted.
Event or Problem Description
It was reported that the drainage was separated into multiple pieces.The target lesion was located in the peri pancreatic area.A 10.3/25 expel drainage catheter was selected for use.During procedure, it was noted that the device was separated into multiple pieces after three weeks.The device was removed and replaced with another of the same expel drainage catheter to complete the procedure.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: 9009743
• Report Number: 2134265-2019-11071
• Device Sequence Number: 2450179
• Product Code: FGE
• UDI-Device Identifier: 08714729860594
• UDI-Public: 08714729860594
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K141335
• 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): 11/05/2019

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: 04/21/2022
• Device Model Number: 32900
• Device Catalogue Number: 32900
• Device Lot Number: 0023676965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1