MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SAVION FLX; WIRE, GUIDE, CATHETER

Model Number	1006
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a guidewire issue occurred.The target lesion was located in the mildly tortuous and non-calcified brachial artery by the elbow joint.After a 5fr non-boston scientific (non-bsc) introducer sheath was advanced, a 0.14 savion wire was inserted to navigate to the brachiocephalic vein and an opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.When the catheter was turned on, the motor drive unit suddenly made an unusual sound and an error message appeared on the console.Under fluoroscopy, the catheter was found to be coiled up in the fistula, wrapping around the wire, making it extremely difficult to remove.The devices could not be pulled out of the 5fr sheath and the catheter was noted to be fractured.A new 8fr sheath was inserted and the fractured device was removed through a basket snare.The wire was noted to be stretched after removal.The procedure was completed using a balloon.No patient complications were reported and no long-term damage was noted on final imaging.The patient fully recovered.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and microscopic inspection revealed that the guidewire was bent and torn at the distal section.Additionally, 30 cm radiopaque polymer sleeve was detached from guidewire and kinked.
Event or Problem Description
It was reported that a guidewire issue occurred.The target lesion was located in the mildly tortuous and non-calcified brachial artery by the elbow joint.After a 5fr non-boston scientific (non-bsc) introducer sheath was advanced, a 0.14 savion wire was inserted to navigate to the brachiocephalic vein and an opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.When the catheter was turned on, the motor drive unit suddenly made an unusual sound and an error message appeared on the console.Under fluoroscopy, the catheter was found to be coiled up in the fistula, wrapping around the wire, making it extremely difficult to remove.The devices could not be pulled out of the 5fr sheath and the catheter was noted to be fractured.A new 8fr sheath was inserted and the fractured device was removed through a basket snare.The wire was noted to be stretched after removal.The procedure was completed using a balloon.No patient complications were reported and no long-term damage was noted on final imaging.The patient fully recovered.

• Brand Name: SAVION FLX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17778004
• Report Number: 2124215-2023-51215
• Device Sequence Number: 14820963
• Product Code: DQX
• UDI-Device Identifier: 08714729978848
• UDI-Public: 08714729978848
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K180726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2025
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0031677646
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown
• Patient Race: White