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

Model Number	83775
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Necrosis (1971); Embolism/Embolus (4438); Pancreatitis (4481)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil pack migrated.A 5mm x 8cm idc-18 soft interlocking detachable coil was selected for use in an embolization procedure to treat a splenic artery aneurysm.Near the end of the procedure, the coil pack migrated downstream at least 5cm distally in the splenic artery.The coil pack contained nine coils.All devices were left inside the patient.The patient was admitted for observation.Tissue necrosis occurred, and the patient was treated for acute pancreatitis.The patient was ultimately discharged.No further patient complications were reported.
Event or Problem Description
It was reported that the coil pack migrated.A 5mm x 8cm idc-18 soft interlocking detachable coil was selected for use in an embolization procedure to treat a splenic artery aneurysm.Near the end of the procedure, the coil pack migrated downstream at least 5cm distally in the splenic artery.The coil pack contained nine coils.All devices were left inside the patient.The patient was admitted for observation.Tissue necrosis occurred, and the patient was treated for acute pancreatitis.The patient was ultimately discharged.No further patient complications were reported.It was further reported that after the procedure, a splenic infarct was confirmed by computerized tomography (ct) showing loss of enhancement of the inferior spleen where the coil pack sat.The infarct remained inert, and no infection occurred; however, a discussion was had for subsequent surgical splenectomy to reduce the chance of possible complications of splenic infarct.This was ultimately not pursued as the patient was okay on conservative management.
Additional Manufacturer Narrative
Correction: h6 patient codes.
Event or Problem Description
It was reported that the coil pack migrated.A 5mm x 8cm idc-18 soft interlocking detachable coil was selected for use in an embolization procedure to treat a splenic artery aneurysm.Near the end of the procedure, the coil pack migrated downstream at least 5cm distally in the splenic artery.The coil pack contained nine coils.All devices were left inside the patient.The patient was admitted for observation.Tissue necrosis occurred, and the patient was treated for acute pancreatitis.The patient was ultimately discharged.No further patient complications were reported.

• Brand Name: IDC
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15900812
• Report Number: 2124215-2022-50004
• Device Sequence Number: 12030043
• Product Code: KRD
• UDI-Device Identifier: 08714729158769
• UDI-Public: 08714729158769
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2023

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: 04/09/2025
• Device Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0029368693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 01/12/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/08/2023; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown