MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83786
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil became stuck.A 035 interlock 2d 4mm x 10cm was the seventh coil used for an internal iliac artery embolization procedure.The lesion anatomy was moderately tortuous and moderately calcified.The coil was advanced through a terumo 4f catheter with continuous flush.The coil was approximately 20cm out from the catheter when it became stuck.It could not be pushed or pulled.The device was removed and the procedure was completed with another of the same device.There were no patient complications.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8175757
• Report Number: 2134265-2018-64428
• Device Sequence Number: 16863909
• Product Code: KRD
• UDI-Device Identifier: 08714729792987
• UDI-Public: 08714729792987
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2018

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: 04/16/2021
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0021998848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 65