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

Model Number	83912
Medical Device Problem Codes	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil was difficult to deploy, requiring a snare to remove.Two 2x4 embold soft detachable coil systems was selected for use during a bleed coiling procedure.During the procedure, the coil was difficult to deploy in the mild to moderately tortuous target location.Several attempts were made to deploy the coil, but difficulty was encountered due to small vasculature.It was noted that the pull wire/detachment wire was broken.A snare was used to retrieve the coil, and the procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, visual and microscopic examination of this 2x4 embold soft detachable coil system revealed a stretched coil that was stuck inside the tip of a truselect microcatheter.Only the coil was received and had no coupler damage.The entire proximal portion of the device was not received.The complaint was not confirmed for issues related to a failure to separate; however, the complaint was confirmed for issues due to coil damage.
Event or Problem Description
It was reported that the coil was difficult to deploy, requiring a snare to remove.Two 2x4 embold soft detachable coil systems was selected for use during a bleed coiling procedure.During the procedure, the coil was difficult to deploy in the mild to moderately tortuous target location.Several attempts were made to deploy the coil, but difficulty was encountered due to small vasculature.It was noted that the pull wire/detachment wire was broken.A snare was used to retrieve the coil, and the procedure was completed with another of the same device.There were no patient complications.

• Brand Name: EMBOLD SOFT 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: 20359284
• Report Number: 2124215-2024-61006
• Device Sequence Number: 15475283
• Product Code: KRD
• UDI-Device Identifier: 00191506026370
• UDI-Public: 00191506026370
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 10/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 83912
• Device Catalogue Number: 83912
• Device Lot Number: 0033378428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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: EMBOLD SOFT 2X4.; EMBOLD SOFT 2X4.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown