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

Model Number 83910

Device Problems Break (1069); Premature Activation (1484); Device-Device Incompatibility (2919); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2023

Event Type  Injury  

Event Description

It was reported that the coil fractured and deployed prematurely.Both pieces of the coil had to be snared.A 10x50 embold fibered detachable coil system was selected for use in a splenic artery embolization procedure.Multiple coils were deployed without issue using a non-boston scientific microcatheter.The physician was attempting to position the embold coil but encountered difficulty in the coil forming as he intended.To assist in positioning, the delivery system was advanced in and out of the microcatheter multiple times.During one of these advancements, the coil broke in half, which prematurely deployed the distal portion of the coil into the artery while the proximal portion of the coil remained in the microcatheter.The proximal portion of the coil was then pushed out into the artery using a syringe.Neither portion of the coil was in an ideal location, so the physician elected to retrieve both fragments.During retrieval of one of the pieces, while pulling back the coil using a snare, the embold coil hooked onto the coil pack and began pulling it back.After some maneuvering, both pieces were retrieved.The procedure was completed using a non-boston scientific coil.

Manufacturer Narrative

Device analysis: returned product consisted of an embold fibered coil 10x50 attached to a snare device.No components of the embold device were returned apart from the coil.The coil showed severe stretching.Inspection of the remainder of the device revealed no other damage or irregularities.The complaint of coil damage was confirmed due to the reported event and the coil returned on the snare device.There was no evidence of any damage or irregularities contributing to the reported premature deployment difficulty, which could not be confirmed because the clinical circumstances could not be replicated.

Event Description

It was reported that the coil fractured and deployed prematurely.Both pieces of the coil had to be snared.A 10x50 embold fibered detachable coil system was selected for use in a splenic artery embolization procedure.Multiple coils were deployed without issue using a non-boston scientific microcatheter.The physician was attempting to position the embold coil but encountered difficulty in the coil forming as he intended.To assist in positioning, the delivery system was advanced in and out of the microcatheter multiple times.During one of these advancements, the coil broke in half, which prematurely deployed the distal portion of the coil into the artery while the proximal portion of the coil remained in the microcatheter.The proximal portion of the coil was then pushed out into the artery using a syringe.Neither portion of the coil was in an ideal location, so the physician elected to retrieve both fragments.During retrieval of one of the pieces, while pulling back the coil using a snare, the embold coil hooked onto the coil pack and began pulling it back.After some maneuvering, both pieces were retrieved.The procedure was completed using a non-boston scientific coil.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16956290
• MDR Text Key: 315504487
• Report Number: 2124215-2023-24323
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729983651
• UDI-Public: 08714729983651
• 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,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• 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: 0030845187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention