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

Model Number	83779
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil detached.The target lesion was located in the pelvic cavity.A 14mm x 30cm f-idc 2d was selected for pelvic vein embolization.During the procedure, a 5f imaging catheter was used to super-select the lesion via the ovarian vein, and the coil was advanced into patient's body along the imaging catheter and to the pelvic embolization position, but could not deploy when the device was delivered.The coil was withdrawn and removed completely but it was found to be broken.The procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the main coil, the pusher wire, and the introducer sheath were returned for the analysis.It was observed that the main coil was bent at the middle section.Functional testing could not be performed since the main coil and the pusher wire were not interlocking.Dimensional inspection confirmed that the outer diameters were within specification.
Event or Problem Description
It was reported that the coil detached.The target lesion was located in the pelvic cavity.A 14mm x 30cm f-idc 2d was selected for pelvic vein embolization.During the procedure, a 5f imaging catheter was used to super-select the lesion via the ovarian vein, and the coil was advanced into patient's body along the imaging catheter and to the pelvic embolization position, but could not deploy when the device was delivered.The coil was withdrawn and removed completely but it was found to be broken.The procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18087935
• Report Number: 2124215-2023-61705
• Device Sequence Number: 18074995
• Product Code: KRD
• UDI-Device Identifier: 08714729765073
• UDI-Public: 08714729765073
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0030595153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 50 KG