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

Model Number M001361580

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

Patient had an embolization for an endo leak.The coil used for the procedure did not deploy properly, a portion of the coil broke off.Patient required surgery to remove retained portion.Manufacturer response for embolization coil, (brand not provided) (per site reporter) they are opening an internal complaint.If the product is located, our legal and risk team is determining if it should be retained by the hospital.

• 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: 14873918
• MDR Text Key: 295054812
• Report Number: 14873918
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/22/2022

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
• Device Operator: Health Professional
• Device Model Number: M001361580
• Device Catalogue Number: M001361580
• Device Lot Number: 29054725
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other