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	04/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The 65% stenosed target lesion was located in the moderately tortuous and moderately calcified tibial vessel.A savion flx guidewire was selected for use.The guidewire was removed intact from the patient.However during reinsertion, the distal tip broke while the device was external to the patient.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: unit returned with its original box, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn and lot provided by the customer.The returned guidewire had the distal tip portion detached and it was not returned.The end distal tip was found bent.No other issues were found.Photos were taken of detached at very tip and distal end bent.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.
Event or Problem Description
It was reported that tip detachment occurred.The 65% stenosed target lesion was located in the moderately tortuous and moderately calcified tibial vessel.A savion flx guidewire was selected for use.The guidewire was removed intact from the patient.However during reinsertion, the distal tip broke while the device was external to the patient.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• Brand Name: SAVION FLX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11826924
• Report Number: 2134265-2021-06095
• Device Sequence Number: 1153653
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 12/08/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0026484675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1