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); Stretched (1601); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil detached in a non-target location and had to be retrieved from the patient with a snare catheter.An embold fibered detachable coil system was selected for use as the first coil in an embolization procedure to treat pulmonary arteriovenous malformations (avms).The target lesion was accessed from the femoral vein and was reported to have moderate tortuosity.During advancement to the target location, the coil had to be rewound three-to-four times due to the device slipping within the vein.It was visualized that the coil had begun to unravel as a result of this.It was attempted to remove the delivery shaft by folding the perforated section of the proximal delivery wire, which resulted in the pull wire breaking externally to the patient and the coil detaching inside the patient.The coil was approached contralaterally and retrieved with a snare catheter.No device fragments remained within the patient.The device was replaced in order to complete the procedure.There were no further adverse consequences reported for the patient.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16727836
• Report Number: 2124215-2023-16664
• Device Sequence Number: 7292978
• Product Code: KRD
• UDI-Device Identifier: 08714729983620
• UDI-Public: 08714729983620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/12/2023

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: 11/14/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0030540222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown