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

Model Number	M001394250060600
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Difficult to Remove (1528); Failure to Advance (2524); Malposition of Device (2616); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil inadvertently deployed outside of the target lesion, requiring additional intervention.An embold soft 6x60 was selected for use to treat a type two endoleak.The target lesion was mildly tortuous.When the embold coil was inserted, the device began to buckle and was reportedly hard to push.The physician began to pull back the device, at which point the coil snapped and detached.The physician attempted to snare the coil, but the coil appeared to fray and come apart.To prevent the coil from migrating down the leg, a stent was placed across the iliac.The patient was expected to fully recover.

• Brand Name: EMBOLD SOFT
• 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: 21315408
• Report Number: 2124215-2025-04477
• Device Sequence Number: 20886426
• Product Code: KRD
• UDI-Device Identifier: 00191506026554
• UDI-Public: 00191506026554
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K230706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/05/2025

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 Model Number: M001394250060600
• Device Catalogue Number: M001394250060600
• Device Lot Number: 0033412741
• 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: 01/07/2025
• Initial Report FDA Received Date: 02/05/2025
• Date Device Manufactured: 02/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White