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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal and thrombosis has progressed.The non stenosed target lesion was located in the moderately tortuous and not severely calcified internal iliac artery.Two 10mm x 50cm interlock coils were selected for use.During the procedure, it was noted that both coils became stuck in the distal part of the catheter.Furthermore, when the coils were removed from the patient's body, it was noted that the devices protruded from the tip of the microcatheter.Physician's comment was that thrombosis progressed while coil was inserted and removed to adjust the shape.The procedure was completed with a different device.No further patient complications were reported.
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal and thrombosis has progressed.The non stenosed target lesion was located in the moderately tortuous and not severely calcified internal iliac artery.Two 10mm x 50cm interlock coils were selected for use.During the procedure, it was noted that both coils became stuck in the distal part of the catheter.Furthermore, when the coils were removed from the patient's body, it was noted that the devices protruded from the tip of the microcatheter.Physician's comment was that thrombosis progressed while coil was inserted and removed to adjust the shape.The procedure was completed with a different device.No further patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that a pusher wire and coil were returned for this complaint.The coil and pusher wire arms were not interlocked.The introducer sheath did not return.The coil was inspected, and it was found kinked and stretched.The pusher wire was inspected, and no damages were found.No more damages were found in the returned device.Microscopic inspection of pusher wire and main coil revealed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Dimensional inspection of the pusher wire and main coil revealed the components were within specification.

• 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: 12100902
• Report Number: 2134265-2021-08158
• Device Sequence Number: 3782489
• Product Code: KRD
• UDI-Device Identifier: 08714729845287
• UDI-Public: 08714729845287
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: 02/21/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0027017448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 06/12/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other