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

Model Number 83910

Device Problems Stretched (1601); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 05dec2023.It was reported that the coil would not advance in the microcatheter and stretched.A 6x20 embold fibered detachable coil system was selected for use in a transsplenic gastric variceal embolization procedure.The microcatheter was flushed; however, the coil would not advance with the microcatheter.The whole system was pulled out.The physician regained access and deployed other embold coils successfully.There were no patient complications.However, device analysis revealed the coil was separated from the distal coupler.

Manufacturer Narrative

Device evaluated by mfr: the delivery sheath, delivery wire and a severely damaged, stretched embold 6x20 coil were returned to boston scientific for analysis.Visual and microscopic analysis was conducted.The perforations were intact.The delivery wire was inside of the delivery sheath with the stretched coil.The distal and proximal couplers were attached to the delivery wire via the pull wire.No damage on the delivery sheath and delivery wire was noticed.The couplers showed slight bends.The coil was severely stretched and separated from the distal coupler.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18380583
• MDR Text Key: 331347874
• Report Number: 2124215-2023-71717
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0031045385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1