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); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an unretrieved device fragment.A 22x60 embold fibered coil was selected for use in the embolization of a splenic artery pseudoaneurysm.The anatomy was moderately tortuous.The coil was advanced through a 2.4fr non-boston scientific microcatheter.While positioning the coil into the pseudoaneurysm, there were quite a few turns, and the coil was not advancing smoothly and began buckling.The physician then tried to pull the coil back out, but it separated.Under fluoroscopy, a "long string of something, some kind of wire, fiber thing" was observed that went all the way down to the groin.The coil was snared, but while doing so, one whole piece broke off.Most of the device was retrieved, but there was still a piece that goes from the pseudoaneurysm through the splenic artery out into the celiac and about 5cm out into the abdominal aorta.The physician did not think this will cause an issue as it was not flow-limiting or causing any obstruction.Flow was still good.The radiopaque part of the coil was mostly in the splenic artery, and there's a less radiopaque part that is very thin and soft which hangs out into the celiac/aorta.Approximately 20-30cm was removed, but the last part was unable to be retrieved.The procedure was completed with a non-boston scientific coil.No further patient complications were reported, and the patient is expected to fully recover.
Event or Problem Description
It was reported that there was an unretrieved device fragment.A 22x60 embold fibered coil was selected for use in the embolization of a splenic artery pseudoaneurysm.The anatomy was moderately tortuous.The coil was advanced through a 2.4fr non-boston scientific microcatheter.While positioning the coil into the pseudoaneurysm, there were quite a few turns, and the coil was not advancing smoothly and began buckling.The physician then tried to pull the coil back out, but it separated.Under fluoroscopy, a "long string of something, some kind of wire, fiber thing" was observed that went all the way down to the groin.The coil was snared, but while doing so, one whole piece broke off.Most of the device was retrieved, but there was still a piece that goes from the pseudoaneurysm through the splenic artery out into the celiac and about 5cm out into the abdominal aorta.The physician did not think this will cause an issue as it was not flow-limiting or causing any obstruction.Flow was still good.The radiopaque part of the coil was mostly in the splenic artery, and there's a less radiopaque part that is very thin and soft which hangs out into the celiac/aorta.Approximately 20-30cm was removed, but the last part was unable to be retrieved.The procedure was completed with a non-boston scientific coil.No further patient complications were reported, and the patient is expected to fully recover.
Additional Manufacturer Narrative
Device eval by manufacturer: the 22x60 embold fibered coil was returned for analysis.The delivery sheath, delivery wire, and a severely damaged, stretched, and tangled coil were returned.Visual and microscopic analysis was conducted.The perforations were intact.The delivery wire was inside of the delivery sheath.The distal and proximal couplers were attached to the delivery wire via the pull wire.No damage on the delivery sheath or delivery wire was noticed.The couplers showed slight bends.The coil was severely stretched and tangled, and there were multiple breaks on the coil wire.The stretched coil was not connected to 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
• 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: 17769516
• Report Number: 2124215-2023-50133
• Device Sequence Number: 6638243
• Product Code: KRD
• UDI-Device Identifier: 08714729983743
• UDI-Public: 08714729983743
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/11/2023

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: 12/22/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0030761580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: 2.4FR PROGREAT; MICROCATHETER: 2.4FR PROGREAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male