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)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

Device evaluation by manufacturer: the product was returned to boston scientific for analysis.The delivery wire and the nitinol shaft were returned.The returned delivery wire showed that it was not broken at the laser cut perforations.The delivery wire was returned with the proximal and distal coupler attached.The coupler showed no damage.The coil was not connected to the distal coupler.The coil was delivered into the patient.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

It was reported that the delivery wire broke, and a device fragment was left inside the patient.An 8x20 embold fibered detachable coil system was selected for use an embolization procedure.The target location was a pseudoaneurysm in the pancreaticoduodenal.The vessel was mildly tortuous.During the procedure, the physician retracted the coil due to a sizing preference.While trying to retract the coil into the sheath, there was resistance, and the polymer shaft of the delivery wire broke.The physician was able to use saline to deploy the coil with the distal fragment of the delivery wire still attached to the coil.The coil and fragment of the delivery wire were left inside the target location, and no attempts were made to retrieve the device fragment.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16610101
• MDR Text Key: 311955639
• Report Number: 2124215-2023-13815
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729983620
• UDI-Public: 08714729983620
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• 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: 0029579225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other