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

Device Problems Break (1069); Fracture (1260); Difficult to Advance (2920); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  Injury  

Event Description

It was reported that the coil sheared off and went to a nearby vessel.An interlock-35 was selected for use.During the procedure, the device had difficulty advancing in the catheter.Furthermore, the coil sheared off and went to a nearby vessel that was part of the bleed.The fragment was not removed since it deployed in a favorable location and the outcome was good.No patient complications were reported.

Manufacturer Narrative

Changed f10 impact code from " f26-no health consequences or impact" to "f16-recognised device or procedural complication.Changed f10 device code from "fracture" to "break".

Event Description

It was reported that the coil sheared off and went to a nearby vessel.An interlock-35 was selected for use.During the procedure, the device had difficulty advancing in the catheter.Furthermore, the coil sheared off and went to a nearby vessel that was part of the bleed.The fragment was not removed since it deployed in a favorable location and the outcome was good.No patient complications were reported.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16619599
• MDR Text Key: 312044355
• Report Number: 2124215-2023-10726
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other