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

Model Number	M001361940
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Early 50¿s male with history of cirrhosis, portal hypertension, obesity and recent gi bleed and portal vein thrombosis.Procedure: transjugular intrahepatic portosystemic shunt (tips) placement, 4 x sclerosis with embolization of large portosystemic shunt and attempted transplenic access to pv system.During the procedure, the bs interlock coil would not come unlatched in the patient.It unlatched when attempting to re-sheath the coil.2nd attempt- coil would not unlatch from wire.3rd attempt- coil came unattached in the microcatheter.In all situations, the 0.021 bern direxion micro cath was used as recommended.No known harm to patient.Manufacturer response for device, vascular, for promoting embolization, interlock¿ (per site reporter).Will obtain.

• Brand Name: INTERLOCK¿
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15282341
• Report Number: 15282341
• Device Sequence Number: 11332393
• Product Code: KRD
• UDI-Device Identifier: 08714729845300
• UDI-Public: (01)08714729845300(19)231206(10)26584803
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/10/2022
• Report Date (Section F): 08/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: M001361940
• Device Catalogue Number: M001361940
• Device Lot Number: 26584803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 187 KG
• Date Report Sent to FDA: 08/10/2022