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

Model Number	83910
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil broke, requiring additional intervention.A 3mm x12cm embold fibered detachable coil system was selected for use in a hemorrhoid embolization procedure.The coil was partially deployed in the rectal artery branch when an attempt was made to reposition; however, resistance was encountered while both pushing and pulling on the delivery wire.An attempt was made to retrieve the coil into the microcatheter.The operator pulled with resistance, and the coil stretched and ultimately broke.The coil separated from the couplers on the delivery wire.Multiple passes were made with both standard 6f snares and microsnares to retrieve portions of the stretched coil.The patient fully recovered.
Event or Problem Description
It was reported that the coil broke, requiring additional intervention.A 3mm x12cm embold fibered detachable coil system was selected for use in a hemorrhoid embolization procedure.The coil was partially deployed in the rectal artery branch when an attempt was made to reposition; however, resistance was encountered while both pushing and pulling on the delivery wire.An attempt was made to retrieve the coil into the microcatheter.The operator pulled with resistance, and the coil stretched and ultimately broke.The coil separated from the couplers on the delivery wire.Multiple passes were made with both standard 6f snares and microsnares to retrieve portions of the stretched coil.The patient fully recovered.It was further reported that the coil appeared to separate between the coil and the distal coupler before multiple passes with snares were made to remove the stretched coil.The remaining coil fragments were left in the non-target inferior mesenteric artery.Approximately how much of the coil was left in the patient was unable to be determined due to the stretched length.The procedure was not completed with another coil, and the target location did not appear sufficiently embolized.

• 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: 18377427
• Report Number: 2124215-2023-72706
• Device Sequence Number: 7579688
• Product Code: KRD
• UDI-Device Identifier: 08714729983552
• UDI-Public: 08714729983552
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 02/28/2024

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: 07/06/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0031965245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male