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

Model Number	83779
Medical Device Problem Codes	Break (1069); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coil was fractured, elongated to the unintended site and was snared.An 18mm x 50cm interlock coil was selected for use.During the procedure, all 17 coils were deployed.However, the 18th coil was fractured in three parts while retracting post deployment.Furthermore, the coil elongated all the way from the ovarian vein to the common femoral access site.The fragment was then removed by upgrading the sheath to 6fr and inserting a snaring device to capture the faulty coil.No further patient complications were reported and the patient was fully recovered.
Event or Problem Description
It was reported that coil was fractured, elongated to the unintended site and was snared.An 18mm x 50cm interlock coil was selected for use.During the procedure, all 17 coils were deployed.However, the 18th coil was fractured in three parts while retracting post deployment.Furthermore, the coil elongated all the way from the ovarian vein to the common femoral access site.The fragment was then removed by upgrading the sheath to 6fr and inserting a snaring device to capture the faulty coil.No further patient complications were reported and the patient was fully recovered.It was further reported that half of the coil nest was in the proximal ovarian vein with a stretched coil segment, up the ovarian vein, along left renal vein, down the ivc and into the external iliac vein.The procedure was aborted after the broken coil was retrieved and no further coils were used.

• 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: 12910857
• Report Number: 2134265-2021-15020
• Device Sequence Number: 4819920
• Product Code: KRD
• UDI-Device Identifier: 08714729845300
• UDI-Public: 08714729845300
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 12/13/2021

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: 07/20/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027875000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: DIREXION 0.021; MICROCATHETER: DIREXION 0.021
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown