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

Model Number	83777
Medical Device Problem Codes	Premature Activation (1484); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used (b)(6) 2021 as the event date was not reported.
Event or Problem Description
It was reported that the coil needed to be snared to remove.A 2/3mmx2.3cm interlock was selected for use.The target lesion was located in a moderately tortuous vessel.During the procedure, the coil was fed into the microcatheter.The physician was not happy with the catheter position, so the coil was pulled out without detaching.The guidewire was placed into the catheter to reposition, but the coil was unexpectedly in microcatheter and was then deployed in suboptimal position.The coil needed to be snared to remove.The procedure was completed with another of the same device.No further patient complications were 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: 11770023
• Report Number: 2134265-2021-04933
• Device Sequence Number: 3192211
• Product Code: KRD
• UDI-Device Identifier: 08714729765080
• UDI-Public: 08714729765080
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2023
• Device Model Number: 83777
• Device Catalogue Number: 83777
• Device Lot Number: 0025680268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER - COOK
• Outcome Attributed to Adverse Event: Required Intervention