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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a coil protrusion occurred.The target lesion was located in the inferior mesenteric artery.A 3mm x 12cm interlock was selected for use in an arteriovenous fistula coil embolization.During coiling, it was noted that the device got unraveled.The coil arm part was being connected with the introducer sheath fit in the hub during insertion.Subsequently, the coil was removed with the microcatheter and continuous flushing was performed.However, upon removal, it was noted that the coil protruded from the catheter's tip.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic inspection revealed that only the main coil was returned for this complaint.The main coil was returned stretched.No more damages were found in the returned device.The zap tip had a smooth surface.The interlocking arm was inspected and no anomalies were noted.A dimensional inspection revealed that the main coil was within its specification aside from the missing number of fiber bundles.
Event or Problem Description
It was reported that a coil protrusion occurred.The target lesion was located in the inferior mesenteric artery.A 3mm x 12cm interlock was selected for use in an arteriovenous fistula coil embolization.During coiling, it was noted that the device got unraveled.The coil arm part was being connected with the introducer sheath fit in the hub during insertion.Subsequently, the coil was removed with the microcatheter and continuous flushing was performed.However, upon removal, it was noted that the coil protuded from the catheter's tip.The procedure was completed with another of the same device.No 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: 9835479
• Report Number: 2134265-2020-03271
• Device Sequence Number: 19135793
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: 08714729764946
• 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,Followup
• Report Date (Section B): 04/29/2020

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: 03/25/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0023694794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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: EXCELSIOR 1018; MICROCATHETER: EXCELSIOR 1018; MICROCATHETER: EXCELSIOR 1018