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

Model Number	83910
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 05dec2023.It was reported that the coil would not advance in the microcatheter and stretched.A 6x20 embold fibered detachable coil system was selected for use in a transsplenic gastric variceal embolization procedure.The microcatheter was flushed; however, the coil would not advance with the microcatheter.The whole system was pulled out.The physician regained access and deployed other embold coils successfully.There were no patient complications.However, device analysis revealed the coil was separated from the distal coupler.
Additional Manufacturer Narrative
Device evaluated by mfr: the delivery sheath, delivery wire and a severely damaged, stretched embold 6x20 coil were returned to boston scientific for analysis.Visual and microscopic analysis was conducted.The perforations were intact.The delivery wire was inside of the delivery sheath with the stretched coil.The distal and proximal couplers were attached to the delivery wire via the pull wire.No damage on the delivery sheath and delivery wire was noticed.The couplers showed slight bends.The coil was severely stretched and separated from the distal coupler.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• 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: 18380583
• Report Number: 2124215-2023-71717
• Device Sequence Number: 12712188
• Product Code: KRD
• UDI-Device Identifier: 08714729983613
• UDI-Public: 08714729983613
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/21/2023

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: 02/13/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0031045385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown