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

Model Number	83910
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H4: the lot number remains unknown; therefore, the manufacture date and expiration date are also unknown.
Event or Problem Description
It was reported the coil unraveled outside of the target location requiring removal using a snare.This embold fibered detachable coil system 14 x 30 was selected for splenic artery embolization to treat an aneurysm.On (b)(6) 2023, the coil unraveled/stretched when being retracted during placement; however, it was thought to be fully contained within the splenic artery.On (b)(6) 2023, image revealed the coil extended from splenic artery down the aorta and into the iliac artery.On (b)(6) 2023, an additional procedure was performed to remove unraveled coil portion.The unraveled portion was separated into fragments and then removed using a snare.On that same day, a follow-up ct showed no residual fragments in aorta/iliac.On (b)(6) 2023, additional imaging confirmed the remaining coil was only in the intended splenic artery.No patient complications were reported.
Additional Manufacturer Narrative
D4, h4: the lot number remains unknown; therefore, the manufacture date and expiration date are also unknown.Device eval by manufacturer: the damaged coil sections of the embold fibered detachable coil system 14 x 30 were returned for analysis (no other embold components were returned).The returned pieces were approximately 8 cm and 30 cm long.Microscopic analysis was conducted, which revealed that both sections of the coil were severely stretched and broken for removal.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 difficultly withdrawing due to the damage observed on the coil.
Event or Problem Description
It was reported the coil unraveled outside of the target location requiring removal using a snare.This embold fibered detachable coil system 14 x 30 was selected for splenic artery embolization to treat an aneurysm.On (b)(6) 2023, the coil unraveled/stretched when being retracted during placement; however, it was thought to be fully contained within the splenic artery.On (b)(6) 2023, image revealed the coil extended from splenic artery down the aorta and into the iliac artery.On (b)(6) 2023, an additional procedure was performed to remove unraveled coil portion.The unraveled portion was separated into fragments and then removed using a snare.On that same day, a follow-up ct showed no residual fragments in aorta/iliac.On (b)(6) 2023, additional imaging confirmed the remaining coil was only in the intended splenic artery.No patient complications were reported.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18034049
• Report Number: 2124215-2023-60049
• Device Sequence Number: 20668660
• Product Code: KRD
• UDI-Device Identifier: 08714729983705
• UDI-Public: 08714729983705
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/30/2023

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 Model Number: 83910
• Device Catalogue Number: 83910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown