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

Model Number	1006
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in a mildly tortuous and moderately calcified proximal anterior tibial artery.A savion flx guidewire was selected for used.However, during arterial peripheral vascular procedure, the device was fractured.Attempts were made to snare the remainder of the device and an additional femoral access and addition supplies were needed to snare from a different approach along with approximately an additional hour of procedure time.Eventually, the wire was straightened by multiple manipulations.The fractured pieces were removed by a pedal access sheath.The procedure was completed with a non-bsc device, and the patient has fully recovered.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in a mildly tortuous and moderately calcified proximal anterior tibial artery.A savion flx guidewire was selected for used.However, during arterial peripheral vascular procedure, the device was fractured.Attempts were made to snare the remainder of the device and an additional femoral access and addition supplies were needed to snare from a different approach along with approximately an additional hour of procedure time.Eventually, the wire was straightened by multiple manipulations.The fractured pieces were removed by a pedal access sheath.The procedure was completed with a non-bsc device, and the patient has fully recovered.
Additional Manufacturer Narrative
Correction: device code corrected from fracture a040101 to detachment of device or device component.Device evaluated by mfr.: the device was returned for analysis.Unit returned with its original box batch overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device returned to this complaint, and it was observed that the guidewire was a fracture in the distal section and the fragment was not returned to this complaint.A part of original box returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed in the device.Under the microscope was observed that the guidewire was a fracture in the distal section.

• 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: jeff wallner wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16421799
• Report Number: 2124215-2023-05574
• Device Sequence Number: 6433058
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/18/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2024
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0029667601
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Race: White