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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coil protrusion occurred.The target lesion was located in the moderately tortuous artery.A 12mm x 30cm and 10mm x 30cm interlock coil was selected for use accordingly.During the procedure, the main coil and the arm of the delivery wire were separated distally from the catheter.Flushing was performed intermittently prior to removing the device.Subsequently, it was noted that the coil protruded from the catheter tip.The coil was removed together with the catheter.The procedure was completed with a different device.No patient complications were reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15459176
• Report Number: 2124215-2022-35481
• Device Sequence Number: 6006375
• Product Code: KRD
• UDI-Device Identifier: 08714729765059
• UDI-Public: 08714729765059
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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: 04/18/2025
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0029429652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER - 5FR TEMPO; GUIDEWIRE - RADI FOCUS; MICRO CATHETER - 10/80 EXCELSIOR
• Patient Sex: Unknown