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

Model Number	M001394240100200
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two devices of the same size were used; however, it could not be confirmed which lot number was the one that stretched.The two lot numbers for the two same size coils implanted were: 32523271 and 32468673.
Event or Problem Description
It was reported that the coil stretched and was protruding from the target location.Two 10x20 embold fibered devices were selected for use for an embolization procedure.During the procedure, upon advancing one of the coils forward through the microcatheter, the coils normal resistance when pushing forward disappeared.It appeared via imaging that the coil stretched, and the coupler could be seen as well as a long area of stretched coil extending into an area they did not intend to coil.Both coils remain implanted.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Two devices of the same size were used; however, it could not be confirmed which lot number was the one that stretched.The two lot numbers for the two same size coils implanted were: 32523271 and 32468673.
Event or Problem Description
It was reported that the coil stretched and was protruding from the target location.Two 10x20 embold fibered devices were selected for use for an embolization procedure.During the procedure, upon advancing one of the coils forward through the microcatheter, the coils normal resistance when pushing forward disappeared.It appeared via imaging that the coil stretched, and the coupler could be seen as well as a long area of stretched coil extending into an area they did not intend to coil.Both coils remain implanted.There were no patient complications as a result of this event.It was further reported that the intended location of the coil was a gastric varices, and the location of the unintended coil was a separate gastric varices.There were no complications related to the location of the coil, and no additional procedures were required.

• Brand Name: EMBOLD? FIBERED
• 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: 21527508
• Report Number: 2124215-2025-13411
• Device Sequence Number: 13151675
• Product Code: KRD
• UDI-Device Identifier: 08714729983637
• UDI-Public: (01)08714729983637(17)260927(10)32523271
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• 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,Followup
• Report Date (Section B): 04/02/2025

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 Expiration Date: 09/27/2026
• Device Model Number: M001394240100200
• Device Catalogue Number: M001394240100200
• Device Lot Number: 0032523271
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/02/2025
• Date Device Manufactured: 09/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10X20 EMBOLD FIBERED; 10X20 EMBOLD FIBERED
• Patient Sex: Unknown