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

Model Number	83910
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coils were protruding from the target location, and there was an unsuccessful snare attempt.This 4x8 embold fibered detachable coil system was selected for use in an embolization procedure.During the procedure, two non-boston scientific coils were used, then the physician wanted a smaller coil.Therefore, this embold coil was used and after packing, it was protruding from the target location.It was therefore retracted once and then pushed back in; however, it became stretched.An attempt was made to snare the coil; however, because the coil was so stretched the filament made it difficult to snare, and it was left in place.There were no patient complications.
Additional Manufacturer Narrative
Correction to b5: describe event or problem.
Event or Problem Description
It was reported that the coils were protruding from the target location, and there was an unsuccessful snare attempt.This 4x8 embold fibered detachable coil system was selected for use in an embolization procedure.During the procedure, two non-boston scientific coils were used, then the physician wanted a smaller coil.Therefore, this embold coil was used and after packing, it was protruding from the target location.It was therefore retracted once and then pushed back in; however, it became stretched.Additionally, issues of difficult to retract/remove and difficult to advance through the guide catheter were also reported.An attempt was made to resheath the coil but was not successful.Additionally, an attempt was made to snare the coil; however, because the coil was so stretched the filament made it difficult to snare, and it was left in place.There were no patient complications.

• 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: 18172947
• Report Number: 2124215-2023-63763
• Device Sequence Number: 7652741
• Product Code: KRD
• UDI-Device Identifier: 08714729983569
• UDI-Public: 08714729983569
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 11/29/2023

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: 02/16/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0031071451
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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