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

Model Number	83910
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: the event date was approximated to (b)(6) 2024 based on the date that boston scientific first became aware of the event.Device analysis: returned product consisted of an embold delivery wire.No other components were returned.Microscopic analysis showed that the coil was separated from the distal coupler.The distal coupler showed a slight bend.Inspection of the remainder of the device revealed no other damage or irregularities.The complaint was confirmed for insertion issues.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.It was reported that the coil was difficult to insert into the microcatheter.An embold fibered detachable coil system was selected for use to treat a bleed.The embold coil was attempted to be inserted into the non-boston scientific microcatheter with intermittent flushing, but the coil would not advance.Use of the embold coil was abandoned, and it was determined that a coil was not necessary to treat the bleed.There were no reported patient complications.However, device analysis revealed that the distal coupler had detached from the main coil.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19299445
• Report Number: 2124215-2024-25116
• Device Sequence Number: 17646312
• Product Code: KRD
• UDI-Device Identifier: 00191506010485
• UDI-Public: 00191506010485
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0032368218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown