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

Model Number 83910

Device Problems Break (1069); Difficult to Remove (1528); Stretched (1601); Malposition of Device (2616); Material Integrity Problem (2978)

Patient Problems Vasoconstriction (2126); Foreign Body In Patient (2687)

Event Date 05/12/2023

Event Type  Injury  

Event 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
• 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 ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17086529
• MDR Text Key: 316840033
• Report Number: 2124215-2023-28812
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729983569
• UDI-Public: 08714729983569
• 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: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: Black Or African American