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

Model Number	83910
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the coil deployed prematurely and stretched out of the target location.Multiple embold fibered detachable coil systems were selected to embolize the gastroduodenal artery (gda) for an upper gastrointestinal bleed.Two 5x15 embold fiber coils were deployed successfully in distal gda.At the gda origin, the 6x20 was difficult to deploy and stretched, causing a few cm of stretched coil to remain in the common hepatic.The physician does not believe that the patient will have any adverse effects from the coil.The gda measured 2.3 distally and 2.5 at the origin.No patient complications were reported.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18975315
• Report Number: 2124215-2024-17967
• Device Sequence Number: 6571103
• Product Code: KRD
• UDI-Device Identifier: 08714729983613
• UDI-Public: 08714729983613
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/25/2024

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: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0032890143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown