MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD FIBERED DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83910
Medical Device Problem Codes	Premature Activation (1484); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil was deployed in a non-target location.A 3mm x 12cm embold fibered coil was selected for use in a varicocele embolization procedure.The plan was to embolize a tributary and then the main vessel.During the procedure, the coil inadvertently detached inside the microcatheter.While attempting to pull the wire back, the coil retracted as well.It seemed the coil had not fully detached.The coil had to be redeployed.The coil was advanced forward and deployed in a more proximal position inside the non-target vessel above the tributary.They could no longer perform the distal embolization.No patient complications were reported.The patient was to be monitored for resolution of symptoms.
Event or Problem Description
It was reported that the coil was deployed in a non-target location.A 3mm x 12cm embold fibered coil was selected for use in a varicocele embolization procedure.The plan was to embolize a tributary and then the main vessel.During the procedure, the coil inadvertently detached inside the microcatheter.While attempting to pull the wire back, the coil retracted as well.It seemed the coil had not fully detached.The coil had to be redeployed.The coil was advanced forward and deployed in a more proximal position inside the non-target vessel above the tributary.They could no longer perform the distal embolization.No patient complications were reported.The patient was to be monitored for resolution of symptoms.It was further reported that the coil was intentionally detached, but the user did not look at fluoroscopy to see that the detachment section was still inside the microcatheter.Nothing was done to correct the coil's placement.An attempt was made to place a coil through the coil to go more distal, but it could not get through.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18247291
• Report Number: 2124215-2023-68033
• Device Sequence Number: 20597919
• Product Code: KRD
• UDI-Device Identifier: 08714729983552
• UDI-Public: 08714729983552
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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 Expiration Date: 05/14/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0031616576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Male