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	12/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient presented with peripheral artery disease (pad).The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left lateral plantar artery.A savion flx guidewire was selected for use.However, the tip of savion flex broke off while navigating the moderately tortuous and calcified plaque.The tip was successfully snared from the patient.The procedure was completed with a non-bsc device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient presented with peripheral artery disease (pad).The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left lateral plantar artery.A savion flx guidewire was selected for use.However, the tip of savion flex broke off while navigating the moderately tortuous and calcified plaque.The tip was successfully snared from the patient.The procedure was completed with a non-bsc device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: device was returned for analysis.The returned guidewire had the distal tip portion with polymer detached.The end distal tip was found kinked.No other issues were found.Photos were taken of polymer detached at very tip and distal end bent.A photo was attached to the complain record and it show the distal tip kinked and polymer jacket detached.

• Brand Name: SAVION FLX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13285064
• Report Number: 2134265-2022-00202
• Device Sequence Number: 4872714
• 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): 02/21/2022

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: 05/20/2023
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0027354922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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: Male