MAUDE Adverse Event Report: BALT USA LLC ECLIPSE 2L; CATHETER, PERCUTANEOUS

Model Number	ECL2L6X12
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor was performing an embolization procedure with a liquid embolic agent (onyx) using an eclipse 2l balloon catheters that is approved for use with this agent.In the course of the procedure, a small portion of the device became embedded in the onyx and was retained within patient (twice, two separate catheters with two separate fragments, both of the same brand).This is not designed as a breakaway catheter and therefore is a device failure, although this is a known occurrence in these complex cases.The retention is not expected to result in significant injury as the fragments are totally embedded in the onyx.

• Brand Name: ECLIPSE 2L
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BALT USA LLC; 29 parke; irvine CA 92618
• MDR Report Key: 12770131
• Report Number: 12770131
• Device Sequence Number: 11843717
• Product Code: DQY
• UDI-Device Identifier: 00818053022968
• UDI-Public: (01)00818053022968(11)210118(17)220118(10)F210100010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/03/2021
• Report Date (Section F): 11/03/2021

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 Model Number: ECL2L6X12
• Device Catalogue Number: N/A
• Device Lot Number: F210100010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 11/03/2021