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	Foreign Body In Patient (2687)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.A savion flx guidewire was selected for use along with an 0.14 rubicon guide catheter to cross the occluded anterior tibial artery.However, the tip of the wire snapped off in the occluded vessel.The physician has no plans in removing the detached fragment as the patient will be in greater risk in trying to retrieve it.The procedure was completed with a different wire.No complications were reported.The patient was fine post procedure and fully recovered.
Additional Manufacturer Narrative
H6 impact codes: changed "no health consequences or impact" to "serious injury/illness impairment".
Event or Problem Description
It was reported that tip detachment occurred.A savion flx guidewire was selected for use along with an 0.14 rubicon guide catheter to cross the occluded anterior tibial artery.However, the tip of the wire snapped off in the occluded vessel.The physician has no plans in removing the detached fragment as the patient will be in greater risk in trying to retrieve it.The procedure was completed with a different wire.No complications were reported.The patient was fine post procedure and 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: 19346944
• Report Number: 2124215-2024-29806
• Device Sequence Number: 17795602
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 06/15/2024
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0029604079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 0.14 RUBICON; GUIDE CATHETER: 0.14 RUBICON
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown