MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83786
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Embolism (1829); Embolism/Embolus (4438)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coil migrated to the renal vein.The target lesion was located in the ovarian vein.A 6mmx20cm interlock-35 was selected for use.During the procedure, the coil was deployed in the ovarian vein but migrated to the renal vein and had to be retrieved using alligator clips.The procedure was cancelled as the ovarian vein was too small.No further patient complications were reported.
Event or Problem Description
It was reported that coil migrated to the renal vein.The target lesion was located in the ovarian vein.A 6mmx20cm interlock-35 was selected for use.During the procedure, the coil was deployed in the ovarian vein but migrated to the renal vein and had to be retrieved using alligator clips.The procedure was cancelled as the ovarian vein was too small.No further patient complications were reported.It was further reported that the device was completely removed from the patient's body.The patient was stable post and the procedure will no longer be reschedule.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11206826
• Report Number: 2134265-2021-00475
• Device Sequence Number: 16989680
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: 08714729793021
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 02/25/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023405547
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 02/04/2021
• 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