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

Model Number	83911
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil was unable to retract during repositioning and detached unexpectedly.The embold packing 60 detachable coil system was selected for triple a endoleak embolization.During coiling of aneurysm sac (endoleak), the physician repositioned the coil to a different part of the aneurysm; however, it would not move while attempting to push forward.They attempted to pull coil through microcatheter without success, and the coil prematurely detached.The coil was partially deployed in the intended position, but a large part of the coil was unraveled and retained in the inferior mesenteric artery (outside of the intended location), where they attempted to remove with a snare unsuccessfully.Procedure was not able to be finished.No patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: this embold packing 60 detachable coil system was returned and analyzed.Visual examination revealed only a small portion of the detached coil received.The wedge lock and introducer sheath were removed at the customer site and was not received.The device was received with the perforations intact.Microscopic examination inspection of the device revealed the coil was stretched/detached from the distal coupler weld with couplers undamaged still locked via pull wire.Analysis confirmed damage consistent with difficulties advancing or withdrawing the device.
Event or Problem Description
It was reported that the coil was unable to retract during repositioning and detached unexpectedly.The embold packing 60 detachable coil system was selected for triple a endoleak embolization.During coiling of aneurysm sac (endoleak), the physician repositioned the coil to a different part of the aneurysm; however, it would not move while attempting to push forward.They attempted to pull coil through microcatheter without success, and the coil prematurely detached.The coil was partially deployed in the intended position, but a large part of the coil was unraveled and retained in the inferior mesenteric artery (outside of the intended location), where they attempted to remove with a snare unsuccessfully.Procedure was not able to be finished.No patient complications.

• Brand Name: EMBOLD PACKING 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: 19477103
• Report Number: 2124215-2024-32262
• Device Sequence Number: 20601113
• Product Code: KRD
• UDI-Device Identifier: 00191506026615
• UDI-Public: 00191506026615
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 08/15/2024

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 Expiration Date: 09/03/2026
• Device Model Number: 83911
• Device Catalogue Number: 83911
• Device Lot Number: 0032982966
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown