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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the coil protruded in the catheter's tip during removal.The target lesion was located in the moderately inferior mesenteric artery.A 6mm x 20cm interlock coil was selected for use.During the procedure, it was noted that the coil got stuck in the distal part of the microcatheter.Furthermore, when the coil was removed from the patient's body, it was noted that the coil protruded from the tip of the 0.021-inch non-boston scientific microcatheter.The procedure was completed with a different device.There were no patient complications reported post procedure.

• 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: 15375315
• Report Number: 2124215-2022-34160
• Device Sequence Number: 17569789
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• 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): 09/07/2022

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: 12/15/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0025045025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER - BREAKTHROUGH2 MARKER 0.021 INCH
• Patient Sex: Unknown