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); Malposition of Device (2616); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Vasoconstriction (2126); Foreign Body In Patient (2687)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil broke and was left in a non-target location.A 4x8 embold fibered detachable coil system was selected for use in a gastroduodenal artery (gda) embolization procedure to treat a gi bleed.The target vessel was not extremely tortuous, but there were branches coming off the gda on the proximal end that needed to be embolized as well.These branches were small and at a hard angle making it difficult to cannulate.They were eventually embolized, but there was some spasming in the main gda after multiple attempts to get into these small vessels.This coil was being placed in the proximal artery but not forming correctly.After multiple attempts, the distal end of the coil hooked into a branch and another attempt was made to form in the main artery.Coil retraction was attempted, but the coil stretched and broke.A 6f snare was used to attempt to snare the stretched coil.It was also attempted to push the coil with a pusher wire.After the failed attempts to retrieve the stretched coil, the procedure was completed.The stretched coil remained in a non-target location.The coil started in the small branch off the gda and was stretched through the common hepatic into the celiac artery.Patient is in stable condition.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17086529
• Report Number: 2124215-2023-28812
• Device Sequence Number: 6088583
• Product Code: KRD
• UDI-Device Identifier: 08714729983569
• UDI-Public: 08714729983569
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/08/2023

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: 01/04/2026
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0030792633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: Black Or African American