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

Model Number	1006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred requiring additional intervention.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified anterior tibial artery (ata).An 18 opticross peripheral catheter was placed in the left leg ante-grade stick over a 0.014 savion flx guidewire.While using the intravascular ultrasound (ivus), the transducer element went out while imaging the arch of the foot.However, it was noted that approximately 10 cm of the distal end of the ivus catheter had fractured off inside the artery upon removing the device.After the device was removed, it was also noted that a small piece of the savion flx guidewire was in the ata.A snare was used to retrieve the piece of savion wire and 18 opticross peripheral catheter.The procedure was completed with a different device and there were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was not returned by the customer; nevertheless, physician has provided pictures of the device.As per pictures provided, it can be observed that the guidewire was bent at the distal section, and the pouch information matches with the complaint information.The device was returned for the analysis.Visual and microscopic inspection revealed that the guidewire was bent and detached at the distal section.No more damages or issues were observed.
Event or Problem Description
It was reported that tip detachment occurred requiring additional intervention.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified anterior tibial artery (ata).An 18 opticross peripheral catheter was placed in the left leg ante-grade stick over a 0.014 savion flx guidewire.While using the intravascular ultrasound (ivus), the transducer element went out while imaging the arch of the foot.However, it was noted that approximately 10 cm of the distal end of the ivus catheter had fractured off inside the artery upon removing the device.After the device was removed, it was also noted that a small piece of the savion flx guidewire was in the ata.A snare was used to retrieve the piece of savion wire and 18 opticross peripheral catheter.The procedure was completed with a different device and there were no patient complications reported.

• 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: 17239150
• Report Number: 2124215-2023-32555
• Device Sequence Number: 6969934
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/07/2023

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: 01/19/2025
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0030893674
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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: Female