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

Model Number	M001394260000150
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil stretched, and a snare was used to push the coil into the lesion.A long sheath was advanced through the internal iliac artery, and through the sheath a 5 french base catheter was advanced.A.021 direxion bern microcatheter was then advanced into the non-calcified and mildly tortuous prostate artery target lesion.The physician embolized that artery and wanted to coil on exit.A few non-boston scientific coils were deployed, then the embold packing 15cm was selected.The coil was prepped and advanced in the normal fashion without difficulty.As the coil was exiting the microcatheter, however, it was noted to look irregular on fluoroscopy.While attempting to remove the coil, it was stretching.The physician advanced a snare to remove the coil, but ultimately the snare ended up detaching the coil and was able to push the coil into the prostate artery.There were no patient complications as a result of this event.

• 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: 22022207
• Report Number: 2124215-2025-25804
• Device Sequence Number: 21036527
• Product Code: KRD
• UDI-Device Identifier: 00191506026585
• UDI-Public: (01)00191506026585(17)271105(10)35219423
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 05/14/2025

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: M001394260000150
• Device Catalogue Number: M001394260000150
• Device Lot Number: 0035219423
• 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: 04/17/2025
• Initial Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 11/05/2024
• 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: Unknown