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	Patient Problem/Medical Problem (2688)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
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
Reported via user medwatch # (b)(4) that the drain fractured and a portion was snared from the patient.An expel drainage catheter with twist-loc hub was used in an abdominal fluid collection drainage 2 months ago.However, it was noted that the fluid was leaking around the drain and was planned to be replaced with a new drainage in interventional radiology.The images taken revealed that the drain was fractured and one fragment was retrieved during the initial procedure.The patient then returned to the interventional radiology the next day and the other fragment was snared and a new drain was placed.No further patient complications were reported.
Event or Problem Description
Reported via user medwatch # (b)(4) that the drain fractured and a portion was snared from the patient.An expel drainage catheter with twist-loc hub was used in an abdominal fluid collection drainage 2 months ago.However, it was noted that the fluid was leaking around the drain and was planned to be replaced with a new drainage in interventional radiology.The images taken revealed that the drain was fractured and one fragment was retrieved during the initial procedure.The patient then returned to the interventional radiology the next day and the other fragment was snared and a new drain was placed.No further patient complications were reported.It was further reported that all fragments of the broken device were retrieved from the patient's body.The patient tolerated the procedure well.
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
Reported via user medwatch # (b)(4) that the drain fractured and a portion was snared from the patient.An expel drainage catheter with twist-loc hub was used in an abdominal fluid collection drainage 2 months ago.However, it was noted that the fluid was leaking around the drain and was planned to be replaced with a new drainage in interventional radiology.The images taken revealed that the drain was fractured and one fragment was retrieved during the initial procedure.The patient then returned to the interventional radiology the next day and the other fragment was snared and a new drain was placed.No further patient complications were reported.It was further reported that all fragments of the broken device were retrieved from the patient's body.The patient tolerated the procedure well.
Additional Manufacturer Narrative
Initial reporter: dr.(b)(6).Date of event is an estimated date based off the aware date as the exact event date was not 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: 8138209
• Report Number: 2134265-2018-63623
• Device Sequence Number: 19268848
• Product Code: FGE
• UDI-Device Identifier: 08714729860600
• UDI-Public: 08714729860600
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 32900
• Device Catalogue Number: 32900
• Device Lot Number: 0022327681
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 11/12/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 12/07/2018; 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 60