MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IDC; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83775
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil got separated.The stenosed target lesion was located in the moderately tortuous vessel.A 2mm x 4cm idc embolics was selected for use.During the procedure, an attempt was made to retract the coil into the outer sheath, but it could not be withdrawn, leading to the coil becoming detached.The device was removed from the patient and the procedure was completed with another of the same device there were no patient complications reported.
Additional Manufacturer Narrative
B5 describe event or problem: updated with additional information.
Event or Problem Description
It was reported that the coil got separated.The stenosed target lesion was located in the moderately tortuous vessel.A 2mm x 4cm idc embolics was selected for use.During the procedure, an attempt was made to retract the coil into the outer sheath, but it could not be withdrawn, leading to the coil becoming detached.The device was removed from the patient and the procedure was completed with another of the same device there were no patient complications reported.It was further reported that the coil detached from the locking arm when retracting.

• Brand Name: IDC
• 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: 20630955
• Report Number: 2124215-2024-67237
• Device Sequence Number: 12739954
• Product Code: KRD
• UDI-Device Identifier: 08714729158691
• UDI-Public: 08714729158691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141378
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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 Model Number: 83775
• Device Catalogue Number: 83775
• Device Lot Number: 0033887006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 04/23/2024
• 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
• Patient Sex: Unknown