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

Model Number	83910
Medical Device Problem Codes	Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of a embold fibered coil system.Visual inspection of the device revealed a detached and missing coil.The wedge lock and introducer sheath were removed at the customer site and were not received.The perforations were intact.Microscopic inspection of the device revealed a detached/missing coil from the distal coupler with no coupler damage.The complaint was confirmed for issues due to a coil separation.
Event or Problem Description
Reportable based on device analysis completed on 01oct2024.It was reported that the coil was difficult to insert.A 2x6 embold fibered detachable coil system was selected for an endovascular aneurysm repair (evar) intubation procedure in the abdominal aorta.During the procedure while using the intermittent flushing method, however, the coil became stuck in the hub part of the catheter.Only the coil was removed as it was.A new embold fibered detachable coil system was used to complete the procedure.No patient complications were reported.However, device analysis revealed a detached and missing coil.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20509934
• Report Number: 2124215-2024-66161
• Device Sequence Number: 8118993
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: 08714729983538
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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: 0033138519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: LEONIS MOVA 0.027
• Patient Sex: Unknown