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); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil stretched from the groin into the aorta.A 2x6 embold fibered detachable coil system was selected for use in a gastrointestinal (gi) bleed embolization procedure.The vessel was mildly tortuous.During the procedure, the coil was attempted to be implanted in an ileocolic branch.After breaking the proximal release perforation and pulling back the pull wire, resistance was experienced removing the delivery system of the coil.The coil stretched from the groin into the aorta.Several hours were spent attempting to snare the coil, but it was unsuccessful.The coil continued to stretch.The patient was sent to the operating room (or).The surgery was successful at retrieving 99% of the coil, but a small amount was left in the distal portion of the vessel.
Additional Manufacturer Narrative
Correction: added h6 device code.Device eval by manufacturer: the device was returned for analysis.The delivery sheath, delivery wire, and a small, retrieved piece of coil were returned.Microscopic analysis showed that the perforations were broken.The delivery wire was returned with no damage.The proximal coupler was attached to the delivery wire.No damage on the delivery sheath or delivery wire was noticed.A small piece of coil was retrieved from the patient's vessel and was returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint was confirmed for stretching and breaks.
Event or Problem Description
It was reported that the coil stretched from the groin into the aorta.A 2x6 embold fibered detachable coil system was selected for use in a gastrointestinal (gi) bleed embolization procedure.The vessel was mildly tortuous.During the procedure, the coil was attempted to be implanted in an ileocolic branch.After breaking the proximal release perforation and pulling back the pull wire, resistance was experienced removing the delivery system of the coil.The coil stretched from the groin into the aorta.Several hours were spent attempting to snare the coil, but it was unsuccessful.The coil continued to stretch.The patient was sent to the operating room (or).The surgery was successful at retrieving 99% of the coil, but a small amount was left in the distal portion of the vessel.

• 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: 18969259
• Report Number: 2124215-2024-17494
• Device Sequence Number: 17784653
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: 08714729983538
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/19/2024

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 Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0033211291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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; Hospitalization
• Patient Sex: Unknown