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 Code	Vasoconstriction (2126)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil broke.The embolization target was the mildly tortuous prostatic artery, <2mm diameter.Target site was accessed with a straight 130cm truselect microcatheter.Access was via right femoral to external iliac to internal iliac (same side) through a diagnostic catheter and introducer sheath.The introducer sheath was a 'crossover' type, allowing it to bend into the internal iliac, with the tip near the ostium of the prostatic artery.Two 2x4 embold fibered coils were deployed at the target site and formed adequately.Another 2x4 was requested but wasn't available, so a 2x6 embold fibered coil was used.Approximately 2cm of the 2x6 coil deployed straight down the vessel and did not take a shape.Retraction of the 2x6 coil was attempted but resulted in coil stretching.Vessel spasm likely occurred, constraining the deployed coil segment and contributing to the coil retraction difficulty.The physician continued to retract the stretched coil, resulting in a coil wire break.The embold delivery wire was then removed from the microcatheter.Both couplers were observed to be attached to the delivery wire, with approximately 1mm of coil wire still attached.A coil pusher was used to attempt to push the stretched coil out of the microcatheter, but it just tracked alongside.The microcatheter was removed from the patient.An 035 wire was then used to attempt to push the stretched coil out of the diagnostic catheter, without success.The diagnostic catheter was then removed from the patient, leaving just the introducer sheath, with the tip still in the internal iliac, near the ostium of the prostatic artery.The physician then cut the tapered tip off of the introducer sheath dilator, creating a blunt end, which he then used to push the coil out of the introducer sheath.This left the proximal portion of the stretched coil in a non-target position within the internal iliac.The physician was satisfied with this positioning and did not consider it a further embolization risk, so the procedure was concluded.No patient complications were reported.

• Brand Name: EMBOLD FIBERED DETACHABLE COIL SYSTEM
• Common Device Name: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14803961
• Report Number: 2134265-2022-07216
• Device Sequence Number: 19986761
• Product Code: KRD
• UDI-Device Identifier: 08714729983538
• UDI-Public: 08714729983538
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 06/24/2022

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: 02/23/2025
• Device Model Number: 83910
• Device Catalogue Number: 83910
• Device Lot Number: 0028931698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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 Sex: Male
• Patient Race: White