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 05/16/2023

Event Type  Injury  

Event Description

It was reported that the device broke, and there was an unretrieved device fragment.An 18x50 embold fibered detachable coil system was selected for use in embolization procedure to treat an aneurysm in the splenic artery.While attempting to retract the coil back into the sheath because the coil was too large, resistance was encountered.The polymer shaft snapped, and the coil broke.No attempts were made to retrieve the shaft fragment.The coil and shaft fragment were left in the target location.More coils were deployed without issue, and the procedure was successfully completed.No further 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; 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: 17097452
• MDR Text Key: 316853974
• Report Number: 2124215-2023-29307
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729983729
• UDI-Public: 08714729983729
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• 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: 0029618523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other