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

Model Number	83095
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that additional intervention was required to retrieve the coil.A 3mm-5mm vortx-35 fibered coil was selected for use in a coiling procedure in a mildly tortuous vessel.When the coil was delivered out of the catheter, the physician noticed that the coil did not form to its shape but stayed straight.The coil was pulled out by using a retrieval snare.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.Visual inspection was performed, and only the main coil was returned.The main coil was found kinked and stretched.Blood was noticed in the main coil.No other damages were found.Microscopic inspection was performed.The apex and base zap tip were inspected, and no damages were found.Dimensional inspection was performed, and the apex and base zap tip were measured to be within specification.The primary coil outer diameter and number of fiber bundles were out of specification.There was fiber loss due to the coil's stretched condition.
Event or Problem Description
It was reported that additional intervention was required to retrieve the coil.A 3mm-5mm vortx-35 fibered coil was selected for use in a coiling procedure in a mildly tortuous vessel.When the coil was delivered out of the catheter, the physician noticed that the coil did not form to its shape but stayed straight.The coil was pulled out by using a retrieval snare.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: VORTX - 35
• 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: 13656754
• Report Number: 2134265-2022-02372
• Device Sequence Number: 5295101
• Product Code: KRD
• UDI-Device Identifier: 08714729237280
• UDI-Public: 08714729237280
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: 03/07/2022
• Device Model Number: 83095
• Device Catalogue Number: 83095
• Device Lot Number: 0023457761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2019
• 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: Required Intervention
• Patient Sex: Unknown