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

Model Number	83779
Medical Device Problem Codes	Component Missing (2306); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was no coil found upon retrieval.The target lesion area was located in the splenic artery.A 14mm x 30cm interlock pe f-idc was selected for use.During the procedure, it was noted that the micro catheter reached the lesion then the physician connected the coil delivery sheath and the micro catheter.The guidewire was advanced into the micro catheter but failed to push the guidewire after about 10cm so the physician retrieved the coil, but there was no coil found.The physician did not check the coil before the procedure and it was confirmed that the coil was not left inside the patient's body.The interlocking detachable arms were kinked.There was no coil inside the micro catheter.The procedure was completed with another of same device.There were no patient complications 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
• MDR Report Key: 10364298
• Report Number: 2134265-2020-10371
• Device Sequence Number: 3043930
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

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: 05/27/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024024930
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 70