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); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: the event date was approximated to (b)(6) 2023 based on the date that boston scientific became aware of the event.D6a - implant date: the implant date was approximated to (b)(6) 2023 based on the date that boston scientific became aware of the event.D6b - explant date: the explant date was approximated to (b)(6) 2023 based on the date that boston scientific became aware of the event.
Event or Problem Description
It was reported that the coil fractured internally, and additional intervention was required to retrieve a portion of the coil.An embold fibered 4x8 was selected for use for an embolization procedure in the gastroduodenal artery (gda).The coil was difficult to retract into the microcatheter and stretched as a result.The coil fractured, and additional intervention was required to remove the coil.A portion of the fractured coil remained implanted in the patient.The patient was expected to fully recover, and the embolization procedure was reported to have been successfully completed.
Event or Problem Description
It was reported that the coil fractured internally, and additional intervention was required to retrieve a portion of the coil.An embold fibered 4x8 was selected for use for an embolization procedure in the gastroduodenal artery (gda).The coil was difficult to retract into the microcatheter and stretched as a result.The coil fractured, and additional intervention was required to remove the coil.A portion of the fractured coil remained implanted in the patient.The patient was expected to fully recover, and the embolization procedure was reported to have been successfully completed.It was further reported that the target aneurysm was accessed using a.016 fathom guidewire and an unknown.021 stc microcatheter.The microcatheter was flushed with saline, and there were no issues loading the coil into the microcatheter.As the coil was advancing within approximately the last 20 cm of the microcatheter, there was increasing resistance and friction.The physician elected to remove the coil from the microcatheter and observed that the coil had become unraveled.There was a long, thin, non-radiopaque filament within the catheter.The entire microcatheter was removed and replaced.The entirety of the coil was removed from the patient and no additional intervention was required.There were no reported patient complications as a result of the device malfunction.

• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18012245
• Report Number: 2124215-2023-58791
• Device Sequence Number: 20679780
• Product Code: KRD
• UDI-Device Identifier: 08714729983569
• UDI-Public: 08714729983569
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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 Model Number: 83910
• Device Catalogue Number: 83910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: .016 FATHOM GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown