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

Model Number 83095

Device Problems Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2024

Event Type  Injury  

Event 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 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.

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
• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18865120
• MDR Text Key: 337199492
• Report Number: 2124215-2024-14263
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729162742
• UDI-Public: 08714729162742
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other