MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thin coil filament snapped and remained inside patient.A 5mm x 15cm pe f-idc coil was selected for use.During the procedure, when deploying the device, it was noted that the coil unraveled, and it was then difficult to remove.Consequently, this left a thin coil filament which snapped with the remaining coil attached to the pusher.The device was removed together with the catheter.The remainder of the thin coil filament was seen in the embolized artery.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: unit returned in a generic plastic bag, stuck into an unknown device.The pusher wire returned stuck inside in a non-boston scientific catheter for the analysis.It was observed that the pusher wire was bent at the distal section.No damages or issues were observed.The functional test could not be performed due to only the pusher wire returned for the analysis.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that a thin coil filament snapped and remained inside patient.A 5mm x 15cm pe f-idc coil was selected for use.During the procedure, when deploying the device, it was noted that the coil unraveled, and it was then difficult to remove.Consequently, this left a thin coil filament which snapped with the remaining coil attached to the pusher.The device was removed together with the catheter.The remainder of the thin coil filament was seen in the embolized artery.No patient complications reported.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17221025
• Report Number: 2124215-2023-33165
• Device Sequence Number: 3023689
• Product Code: KRD
• UDI-Device Identifier: 08714729764984
• UDI-Public: 08714729764984
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: 10/31/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030634616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown