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

Model Number	1006
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire broke, requiring additional intervention.This savion flx guidewire was selected for use in a percutaneous transluminal angioplasty (pta) procedure of the crural arteries below the knee.This guidewire had a smooth passage to the 20% stenosed, mildly calcified anterior tibial artery with no difficulties obtaining the correct positioning of the guidewire.Then pta was successfully performed with a non-boston scientific balloon over this guidewire.The balloon was removed and was replaced with a larger balloon; however, when advancing the larger balloon, resistance was felt, and it was noted the non-boston scientific catheter was not at the same location as the guidewire.It was then visualized that the guidewire was broken approximately 30cm from the tip.The piece of guidewire was removed via snaring and the procedure was completed using a new guidewire.There were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this savion flx guidewire was returned split into two pieces.Visual and microscopic inspection revealed that the guidewire was kinked and detached at the distal section.No additional damages or issues were observed.The clinical observations were confirmed due to the condition of the device.
Event or Problem Description
It was reported that the guidewire broke, requiring additional intervention.This savion flx guidewire was selected for use in a percutaneous transluminal angioplasty (pta) procedure of the crural arteries below the knee.This guidewire had a smooth passage to the 20% stenosed, mildly calcified anterior tibial artery with no difficulties obtaining the correct positioning of the guidewire.Then pta was successfully performed with a non-boston scientific balloon over this guidewire.The balloon was removed and was replaced with a larger balloon; however, when advancing the larger balloon, resistance was felt, and it was noted the non-boston scientific catheter was not at the same location as the guidewire.It was then visualized that the guidewire was broken approximately 30cm from the tip.The piece of guidewire was removed via snaring and the procedure was completed using a new guidewire.There were no patient complications.

• 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: 17728495
• Report Number: 2124215-2023-48432
• Device Sequence Number: 15088760
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/25/2023

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: 01/24/2025
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0030918932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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