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

Model Number	83779
Medical Device Problem Codes	Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dissection occurred.The target lesion was located in the right hepatic artery.A 2mm x 6cm interlock was selected for use.During the procedure, the coil was deployed to first implement embo with the a1 nomar branch of right hepatic artery.However, it was noted that the coil wire was not deployed as the coil wire was kinked in the microcatheter.Thus, the first attempted coil was removed and discarded.A product with the same size was tried again, however when the device was pushed hard, a vessel dissection was noticed.The device was removed and discarded and the procedure was completed with a different device.No further patient complications reported.
Event or Problem Description
It was reported that dissection occurred.The target lesion was located in the right hepatic artery.A 2mm x 6cm interlock was selected for use.During the procedure, the coil was deployed to first implement embo with the a1 nomar branch of right hepatic artery.However, it was noted that the coil wire was not deployed as the coil wire was kinked in the microcatheter.Thus, the first attempted coil was removed and discarded.A product with the same size was tried again, however when the device was pushed hard, a vessel dissection was noticed.The device was removed and discarded and the procedure was completed with a different device.No further patient complications reported.It was further reported that when the physician pushed the idc wire, and the coil didn't move into the microcatheter, it was moved by force.A mild-flow limiting-dissection was noted but was recovered normally after around 20 minutes.However, additional coiling was performed by using a non boston scientific device.No fragments remained in the patient's body.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14708615
• Report Number: 2134265-2022-06629
• Device Sequence Number: 5075282
• Product Code: KRD
• UDI-Device Identifier: 08714729845270
• UDI-Public: 08714729845270
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: 05/17/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0025605802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 06/19/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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 Age: 71 YR
• Patient Sex: Female