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

Model Number	83779
Medical Device Problem Codes	Break (1069); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device separation occurred.A 14mm x 50cm interlock was selected for use in a splenic artery aneurysm embolization procedure.8 interlock.018 coils had been previously deployed without issue into the splenic artery aneurysm.However, the last interlock coil would not fully deploy inside aneurysm, so decision was made to re-sheath and remove coil.However, when trying to remove the coil it became detached from the pusher wire.There was no success after attempts were made to advance the coil via wire insertion and flushing.Moreover, when trying to remove the coil, it became stretched and then broke.A small part of the coil remained in the splenic artery.An attempt was performed to remove the detached component but was unsuccessful.Although it did restrict some blood flow through the splenic artery, blood flow to spleen was checked and confirmed.The procedure was completed.There were no patient complications/.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17128663
• Report Number: 2124215-2023-30381
• Device Sequence Number: 7377066
• Product Code: KRD
• UDI-Device Identifier: 08714729845294
• UDI-Public: 08714729845294
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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: 07/04/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0029889987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown