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

Model Number	83787
Medical Device Problem Codes	Premature Activation (1484); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the coil was protruding from the tip of the catheter upon removal from the patient.A 8mm/20cm 0.35 interlock was selected for the abdominal aortic aneurysm repair procedure.The target lesion was moderately calcified.During the procedure, the coil was able to advance to the distal part of the imager ii catheter, but it then became stuck after protruding from the tip of the catheter, and curled 2 or 3 times.Then the interlocking arm of the coil unlocked from the interlocking arm of the pusher wire while moving.The coil was removed together with the catheter as one unit.No device fragments were left inside of the patient.The procedure was complete with this device.No complications reported.

• 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: 8052766
• Report Number: 2134265-2018-62704
• Device Sequence Number: 16591080
• Product Code: KRD
• UDI-Device Identifier: 08714729793052
• UDI-Public: 08714729793052
• 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): 11/08/2018

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: 11/30/2019
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0019933541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1