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

Model Number 83910

Device Problems Break (1069); Premature Activation (1484); Difficult to Remove (1528); Stretched (1601)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/19/2023

Event Type  Injury  

Event Description

It was reported that there was an unretrieved device left in the patient following an unsuccessful snare attempt.An embold fibered 6x20 was selected for use in the embolization procedure to treat a gastroduodenal artery (gda) aneurysm.The target vessel was reported to be tortuous.When the coil was attempted to be reconstrained in the microcatheter for better placement, there was resistance encountered, and the coil appeared to stretch.The physician continued to retract the delivery wire, at which point several snapping sensations were felt, and the coil detached at the polymer shaft, distal to the proximal coupler.The delivery wire was withdrawn from the microcatheter, and a snare was used to attempt to retrieve the coil.The coil was unable to be retrieved, and the stretched coil ultimately remained in the patient.The procedure was completed.There were no reported patient complications as a result of the unretrieved device.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Type of Device: 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 ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17137881
• MDR Text Key: 317267070
• Report Number: 2124215-2023-30653
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729983613
• UDI-Public: 08714729983613
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0030976309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other