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

Model Number	83786
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device became fractured and required snaring.A.035 interlock 2d 6mm x 10cm embolic coil was selected for use in an embolization procedure.During deployment and removal of the interlock, the device fractured.Subsequently, a snare was performed to remove the detached portion from the patient's body.The procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that the device became fractured and required snaring.A.035 interlock 2d 6mm x 10cm embolic coil was selected for use in an embolization procedure.During deployment and removal of the interlock, the device fractured.Subsequently, a snare was performed to remove the detached portion from the patient's body.The procedure was completed with a different device.There were no patient complications reported.It was further reported that there were no fibers left in the patient.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil was returned for this complaint.The coil was inspected, and it was found kinked and stretched.Also, a non-boston scientific device was returned.No more damages were found in the returned device.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Dimensional inspection of the main coil that could be measured were performed and revealed that the outer diameter (od) of the zap tip and primary coil were within specifications.However, the number of distal and proximal fiber bundles were lacking.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11314557
• Report Number: 2134265-2021-01494
• Device Sequence Number: 11441358
• Product Code: KRD
• UDI-Device Identifier: 08714729793007
• UDI-Public: 08714729793007
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133208
• 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,Followup
• Report Date (Section B): 05/14/2021

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: 10/06/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026138500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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: Required Intervention