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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by manufacturer: the embold fibered coil system was returned to boston scientific for analysis.Visual and microscopic inspections of the device revealed a stretched and detached coil.The wedge lock, introducer sheath and the entire proximal delivery section was removed at the customer site and was not received.Only the coil was received inside the introducer sheath with blood.Microscopic inspection of the device revealed the coil was stretched and detached from the distal coupler.Only a portion of the coil and introducer sheath was received.Inspection of the returned device revealed a stretched and detached coil.The complaint was confirmed for issues related to coil damage.
Event or Problem Description
Reportable based on device analysis completed on 06sep2024.It was reported that the coil detached early in the catheter.The 75% stenosed target lesion was located in the moderately tortuous inferior mesenteric artery.A 5x15 embold fibered detachable coil system was selected for an endovascular aneurysm repair.The coil was once attempted to be placed; however, it was recaptured into the introducer sheath to readjust the placement site.The coil unraveled inside the introducer sheath when the delivery wire was pulled during recapture, making it unable to be used.Another embold fibered detachable coil system was used to complete the procedure.No patient complications were reported.However, device analysis revealed the coil was stretched and detached from the distal coupler.

• 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20359474
• Report Number: 2124215-2024-56177
• Device Sequence Number: 12583825
• Product Code: KRD
• UDI-Device Identifier: 08714729983590
• UDI-Public: 08714729983590
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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: 0032844211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BREAKTHROUGH CATHETER
• Patient Sex: Unknown