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

Model Number	M001394240030060
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Muscle Weakness/Atrophy (1967); Nausea (1970); Pain (1994); Sepsis (2067); Vomiting (2144); Unspecified Kidney or Urinary Problem (4503); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis: the product was returned to boston scientific for analysis.Returned product consisted of a embold fibered coil system.No introducer sheath was received.Visual examination revealed the coil was stretched and detached, with only a partial coil received.Perforations were intact.Microscopic examination of the device revealed a partial coil that was stretched and detached from the distal coupler weld with a bent proximal coupler.The complaint was confirmed for issues due to coil damage.
Event or Problem Description
It was reported that additional intervention was required to retrieve the coil.An embold fibered detachable coil system was selected for use in a renal embolization procedure.The target vessel was reported to be mildly tortuous.During the procedure, there was difficulty experienced both advancing the coil within the microcatheter and withdrawing from the microcatheter.Although the proximal release mechanism was not broken, the coil stretched and deployed within the patient prematurely.As a result, a snare was used to remove the coil from the patient.The procedure was successfully completed using an alternate embolization device.There were no patient complications as a result of the intervention.
Additional Manufacturer Narrative
Device analysis: the product was returned to boston scientific for analysis.Returned product consisted of a embold fibered coil system.No introducer sheath was received.Visual examination revealed the coil was stretched and detached, with only a partial coil received.Perforations were intact.Microscopic examination of the device revealed a partial coil that was stretched and detached from the distal coupler weld with a bent proximal coupler.The complaint was confirmed for issues due to coil damage.
Event or Problem Description
It was reported that additional intervention was required to retrieve the coil.An embold fibered detachable coil system was selected for use in a renal embolization procedure.The target vessel was reported to be mildly tortuous.During the procedure, there was difficulty experienced both advancing the coil within the microcatheter and withdrawing from the microcatheter.Although the proximal release mechanism was not broken, the coil stretched and deployed within the patient prematurely.As a result, a snare was used to remove the coil from the patient.The procedure was successfully completed using an alternate embolization device.There were no patient complications as a result of the intervention.It was further reported that the previously reported additional intervention required the surgery time to be extended by approximately 4 hours.Following the surgery, the patient became septic and remained hospitalized for 6 days.Following discharge, she continued with pain, nausea and vomiting.On (b)(6) 2024, she returned to the healthcare facility and was noted to have severe infection and kidney damage.She remained hospitalized for 21 days, suffering from multiple infections and other difficulties.At the time of reporting, the patient continued to suffer with weakness and abnormal kidney function.
Additional Manufacturer Narrative
Corrected fields: h6 - evaluation result codes, evaluation conclusion codes.Device analysis: the product was returned to boston scientific for analysis.Returned product consisted of a embold fibered coil system.No introducer sheath was received.Visual examination revealed the coil was stretched and detached, with only a partial coil received.Perforations were intact.Microscopic examination of the device revealed a partial coil that was stretched and detached from the distal coupler weld with a bent proximal coupler.The complaint was confirmed for issues due to coil damage.
Event or Problem Description
It was reported that additional intervention was required to retrieve the coil.An embold fibered detachable coil system was selected for use in a renal embolization procedure.The target vessel was reported to be mildly tortuous.During the procedure, there was difficulty experienced both advancing the coil within the microcatheter and withdrawing from the microcatheter.Although the proximal release mechanism was not broken, the coil stretched and deployed within the patient prematurely.As a result, a snare was used to remove the coil from the patient.The procedure was successfully completed using an alternate embolization device.There were no patient complications as a result of the intervention.It was further reported that the previously reported additional intervention required the surgery time to be extended by approximately 4 hours.Following the surgery, the patient became septic and remained hospitalized for 6 days.Following discharge, she continued with pain, nausea and vomiting.On (b)(6) 2024, she returned to the healthcare facility and was noted to have severe infection and kidney damage.She remained hospitalized for 21 days, suffering from multiple infections and other difficulties.At the time of reporting, the patient continued to suffer with weakness and abnormal kidney function.
Additional Manufacturer Narrative
Device analysis: the product was returned to boston scientific for analysis.Returned product consisted of a embold fibered coil system.No introducer sheath was received.Visual examination revealed the coil was stretched and detached, with only a partial coil received.Perforations were intact.Microscopic examination of the device revealed a partial coil that was stretched and detached from the distal coupler weld with a bent proximal coupler.The complaint was confirmed for issues due to coil damage.
Event or Problem Description
It was reported that additional intervention was required to retrieve the coil.An embold fibered detachable coil system was selected for use in a renal embolization procedure.The target vessel was reported to be mildly tortuous.During the procedure, there was difficulty experienced both advancing the coil within the microcatheter and withdrawing from the microcatheter.Although the proximal release mechanism was not broken, the coil stretched and deployed within the patient prematurely.As a result, a snare was used to remove the coil from the patient.The procedure was successfully completed using an alternate embolization device.There were no patient complications as a result of the intervention.It was further reported that the previously reported additional intervention required the surgery time to be extended by approximately 4 hours.Following the surgery, the patient became septic and remained hospitalized for 6 days.Following discharge, she continued with pain, nausea and vomiting.On (b)(6) 2024, she returned to the healthcare facility and was noted to have severe infection and kidney damage.She remained hospitalized for 21 days, suffering from multiple infections and other difficulties.At the time of reporting, the patient continued to suffer with weakness and abnormal kidney function.

• 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: 20558397
• Report Number: 2124215-2024-67590
• Device Sequence Number: 8866116
• Product Code: KRD
• UDI-Device Identifier: 08714729983545
• UDI-Public: (01)08714729983545(17)260706(10)31965231
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K213398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/24/2026

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: 07/06/2026
• Device Model Number: M001394240030060
• Device Catalogue Number: M001394240030060
• Device Lot Number: 0031965231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 09/29/2025; 12/05/2025; 02/20/2026
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 10/27/2025; 12/22/2025; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female