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

Model Number M001361530

Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 01/03/2021

Event Type  malfunction  

Event Description

During ir procedure for a coiling of an aneurysm in the gda, one of the coils deployed incorrectly and migrated to sma.The coil did not deploy exactly in the area desired; however, it did not cause any damage.Retrieval was attempted, but unsuccessful.

• Brand Name: INTERLOCK
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11384691
• MDR Text Key: 233739593
• Report Number: 11384691
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2021,02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M001361530
• Device Catalogue Number: M001361530
• Device Lot Number: 22574567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2021
• Date Report to Manufacturer: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA