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

Model Number	83786
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2018
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 a coil protruded at the tip of the catheter.The target lesion was located in a moderately tortuous aneurysm.A 2dx20cm.035 interlock was selected for embolization of thoracoabdominal aortic aneurysm.During the procedure, a stent graft was placed from the femoral just above the superior mesenteric artery.The device was then placed in the distal end of the stent graft to prevent endo leak after placing the 20-40cube and 18-40 2d sequentially for a total of 8 coils; however, it was noted that the coil became stuck inside the imager 2 catheter and could not be pushed forward.Subsequently, the coil protruded out from the tip of the catheter and was exposed in the blood vessel but was able to be pulled back into the catheter.The device was then carefully pulled out from the patient's body.There were no patient complications noted and the patient's condition was stable.

• 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: 7919479
• Report Number: 2134265-2018-61309
• Device Sequence Number: 2014702
• Product Code: KRD
• UDI-Device Identifier: 08714729797432
• UDI-Public: 08714729797432
• 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): 09/28/2018

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: 11/13/2020
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0021383373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1