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	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the guidewire broke.The patient was being treated for critical limb ischemia.The 85% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.A savion flx guidewire was used during vascular angioplasty.However, while trying to cross the lesion, the tip of the guidewire broke.The fractured portion of the device was pulled and removed from the patient's body.No patient complications were reported.
Event or Problem Description
It was reported that the tip of the guidewire broke.The patient was being treated for critical limb ischemia.The 85% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.A savion flx guidewire was used during vascular angioplasty.However, while trying to cross the lesion, the tip of the guidewire broke.The fractured portion of the device was pulled and removed from the patient's body.No patient complications were reported.
Additional Manufacturer Narrative
Device and media analysis: only the complaint device packaging was returned for analysis, without the complaint device.As such, a physical investigation of the complaint device was unable to be performed.Additionally, the reported damage to the device was unable to be confirmed from the media provided by the healthcare facility.

• 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: 19777611
• Report Number: 2124215-2024-40075
• Device Sequence Number: 8278844
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2026
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0033220046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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
• Patient Sex: Male