MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VORTX - 35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83095
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coil break occurred.The patient underwent an embolization where the target lesion was located in a mildly tortuous varicocele.A 3mm/6mm vortx-35 coil was used for this treatment and was advanced all the way into the catheter.During procedure, the second pushable coil came out straight and rigid, it did not loop.Both ends of the coil were detached.The detached portion was not removed but remained implanted.The procedure was completed using an embolic glue.No complications were reported.
Event or Problem Description
It was reported that coil break occurred.The patient underwent an embolization where the target lesion was located in a mildly tortuous varicocele.A 3mm/6mm vortx-35 coil was used for this treatment and was advanced all the way into the catheter.During procedure, the second pushable coil came out straight and rigid, it did not loop.Both ends of the coil were detached.The detached portion was not removed but remained implanted.The procedure was completed using an embolic glue.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: device was not returned, but pictures attached to the complaint show no broken sections, and that it is possible to observe two coils periph where the main coils were bent at the primary coil and stretched at the zap tips sections.However, based on the time event the device, was not damaged before entering the patient, therefore the most likely cause of the reported problem cannot be established due to the lack of testing, so without a proper evaluation of the device, the most likely causes that contributed to the event are unknown.

• Brand Name: VORTX - 35
• Common Device Name: 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18865120
• Report Number: 2124215-2024-14263
• Device Sequence Number: 3338406
• Product Code: KRD
• UDI-Device Identifier: 08714729162742
• UDI-Public: 08714729162742
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: 05/22/2026
• Device Model Number: 83095
• Device Catalogue Number: 83095
• Device Lot Number: 0031674573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown