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

Model Number	M001394240020040
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil prematurely deployed and malpositioned, which required snaring.A 2mm x 4cm embold fibered coil was selected for use in an adrenal myelolipoma.An attempt was made to deploy the coil through a 105cm truselect microcatheter.The area of interest was a branch of the adrenal.The physician did not like the coil's position, so an attempt was made to retract the coil, but only the delivery wire came back, not the coil itself.No resistance was felt when trying to pull the coil back, and the proximal release perforation was not snapped and remained intact.An 016 coil pusher was used to try and push the coil out, but this was unsuccessful.The microcatheter was able to be removed, but the coil and string from the delivery wire were still in the base catheter.A non-boston scientific guidewire was used to try and push the coil through.It looked better, but the string was still in the base catheter.While attempting to remove the guidewire, the base catheter flipped the coil into the aorta.Contralateral access was obtained in order to snare out the coil and string.The patient was hemodynamically stable, and there were no complications post case.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.Visual examination revealed a stretched and detached partial coil.The introducer sheath was not returned.The perforations were intact.Microscopic examination revealed that the partial coil was detached at the distal coupler weld.There was no coupler damage.Media was returned in the form of a photo.The photo was reviewed which showed the device coil was detached/separated.
Event or Problem Description
It was reported that the coil prematurely deployed and malpositioned, which required snaring.A 2mm x 4cm embold fibered coil was selected for use in an adrenal myelolipoma.An attempt was made to deploy the coil through a 105cm truselect microcatheter.The area of interest was a branch of the adrenal.The physician did not like the coil's position, so an attempt was made to retract the coil, but only the delivery wire came back, not the coil itself.No resistance was felt when trying to pull the coil back, and the proximal release perforation was not snapped and remained intact.An 016 coil pusher was used to try and push the coil out, but this was unsuccessful.The microcatheter was able to be removed, but the coil and string from the delivery wire were still in the base catheter.A non-boston scientific guidewire was used to try and push the coil through.It looked better, but the string was still in the base catheter.While attempting to remove the guidewire, the base catheter flipped the coil into the aorta.Contralateral access was obtained in order to snare out the coil and string.The patient was hemodynamically stable, and there were no complications post case.

• Brand Name: EMBOLD FIBERED
• 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: 21125271
• Report Number: 2124215-2024-83514
• Device Sequence Number: 6957665
• Product Code: KRD
• UDI-Device Identifier: 08714729983521
• UDI-Public: 08714729983521
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 02/03/2025

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: M001394240020040
• Device Catalogue Number: M001394240020040
• Device Lot Number: 0034382649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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: BENSON GUIDEWIRE.; BENSON GUIDEWIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Unknown