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

Model Number	83779
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of the event: 18 years or older.
Event or Problem Description
It was reported that the locking arm was separated the target lesion was located at moderately tortuous celiac.A 10mm/20cm interlock device was selected for embolization of the celiac.During the procedure, the device was attempted to be delivered using a non bsc microcatheter, but it was unable to be pushed into the catheter, so it was removed from the patient's body.It was suspected that the coil was defective, so the procedure was continued after replacing the coil with another of the same (this complaint device).However, the second coil became stuck and couldn't be pushed when it was started to coil up slightly in the celiac.When the coil was attempted to be pulled back, the interlocking arm of the coil detached from the interlocking arms of the pusher wire due to the device being pulled forcibly while it was stuck.The microcatheter was removed.The coil did not remain inside the patient; it was removed using a snare.The procedure was completed with different devices.No complications reported and patient's condition is good.

• 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: 8006265
• Report Number: 2134265-2018-62317
• Device Sequence Number: 1531413
• Product Code: KRD
• UDI-Device Identifier: 08714729765028
• UDI-Public: 08714729765028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/25/2018

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: 05/01/2020
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0020715044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1