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

Model Number	83910
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil fractured within the patient, and additional intervention was unable to retrieve all fragments of the coil.An embold fibered detachable coil system was selected for use in the embolization procedure to treat bleeding within a visceral artery.This was intended to be the last coil placed via a non-bsc catheter, after placing another embold coil.The end of the embold coil was reported to be bent and there was visible coupling wire pulled back.The physician thought the coil was outside the microcatheter tip, and tried to pull back the nitinol wire, but the coil was still attached.The coil was advanced again, more of the nitinol wire was pulled back, but the coil was still attached.The physician then decided to remove the coil from the microcatheter and the patient.It was not confirmed the coil was outside the microcatheter.The microcatheter was flushed with no issue under fluoroscopy.Another coil was opened, and upon insertion, it was discovered the previous coil was still in the microcatheter.Since the microcatheter had moved back, the second coil was pushed into a non-target location.The replacement coil was removed and not deployed.The physician attempted to snare the second embold, but the coil kept breaking apart.A portion of the coil was able to be snared successfully, and the portion of the coil that remained in the patient was able to be pushed partially into the existing coil nest.The tail end of the coil extended to a more proximal portion of the target vessel and may have covered a side branch of the visceral vessel unintentionally.A greater portion of the vessel was embolized than intended.However, the intended vessel occlusion was successful, and the patient was reported to have recovered fully.
Additional Manufacturer Narrative
Corrected: h6 - impact codes: the impact codes of f15: recognized device or procedural complication and f10: inadequate/inappropriate treatment or diagnostic exposure were updated to f0103: unexpected therapeutic effects.Device analysis: the delivery wire was returned.No other components were returned for analysis.The returned delivery wire showed the polymer shaft was attached as well as the proximal coupler.The proximal coupler component was not damaged.The perforations were broken, and the pull wire was pulled completely out of the delivery wire.Inspection of the remainder of the device revealed no damage or irregularities.The complaints of kinks on the main coil, breaks on the coil, or delayed separation were unable to be confirmed due to the components not returning for analysis.
Event or Problem Description
It was reported that the coil fractured within the patient, and additional intervention was unable to retrieve all fragments of the coil.An embold fibered detachable coil system was selected for use in the embolization procedure to treat bleeding within a visceral artery.This was intended to be the last coil placed via a non-bsc catheter, after placing another embold coil.The end of the embold coil was reported to be bent and there was visible coupling wire pulled back.The physician thought the coil was outside the microcatheter tip, and tried to pull back the nitinol wire, but the coil was still attached.The coil was advanced again, more of the nitinol wire was pulled back, but the coil was still attached.The physician then decided to remove the coil from the microcatheter and the patient.It was not confirmed the coil was outside the microcatheter.The microcatheter was flushed with no issue under fluoroscopy.Another coil was opened, and upon insertion, it was discovered the previous coil was still in the microcatheter.Since the microcatheter had moved back, the second coil was pushed into a non-target location.The replacement coil was removed and not deployed.The physician attempted to snare the second embold, but the coil kept breaking apart.A portion of the coil was able to be snared successfully, and the portion of the coil that remained in the patient was able to be pushed partially into the existing coil nest.The tail end of the coil extended to a more proximal portion of the target vessel and may have covered a side branch of the visceral vessel unintentionally.A greater portion of the vessel was embolized than intended.However, the intended vessel occlusion was successful, and the patient was reported to have recovered fully.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17192944
• Report Number: 2124215-2023-32097
• Device Sequence Number: 7461827
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: 08714729983538
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 03/05/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0031175345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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