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

Model Number	M001394260000600
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil broke.An embold packing 60cm coil was selected for use in a hemorrhoid embolization procedure.The 2-3mm target vessel was mildly tortuous.One to two embold fibered coils were deployed before attempting to finish with this 60cm packing coil.The coil was advanced into a collateral vessel feeding the hemorrhoid.The last 5cm did not have enough room, and it went into a parent artery that the interventional radiologist did not want to embolize.Since the coil was too long by 5cm, the coil was retracted.30cm of the coil was pulled out without issue until they got to a small turn in a rectal artery, and the packing coil got caught on something.The coil would no longer retract.The coil was pulled harder to get it out, but the coil snapped and detached in the microcatheter.The coil filament ended up snapping after the coil became stretched from the pulling/retraction.An attempt was made to flush the coil out of the microcatheter with saline; however, it was noticed that coil filament was stuck in the sheath.The whole delivery system (including diagnostic) had to be taken out to ensure the whole coil was removed from the patient.Upon removal of the delivery system, a stretched coil was found in the sheath.No additional coil was implanted.The procedure was completed, and no patient complications were reported.

• Brand Name: EMBOLD PACKING
• 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: 21161812
• Report Number: 2124215-2025-01101
• Device Sequence Number: 20940758
• Product Code: KRD
• UDI-Device Identifier: 00191506026615
• UDI-Public: 00191506026615
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• 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
• Report Date (Section B): 01/15/2025

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: M001394260000600
• Device Catalogue Number: M001394260000600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown