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 Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire tip detachment occurred.The target lesion was located in the calcified tibial vessels.A savion flx guide wire was advanced to cross the lesion and then switched out to treat with a non-boston scientific atherectomy device using a non-boston scientific guidewire.The savion crossed well the first two vessels.Before placing it back into patient's body for the third vessel, the physician straightened the tip with his finger and the tip of the wire fell off.The procedure was completed with another savion wire.No patient complications were reported and the patient's status was doing well.
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 bent and a small portion of the polymer jacket detached and not returned.Microscopic inspection revealed polymer jacket detached and not returned confirmed.The device was measured in three sections.The od of the overall length and distal section were unable to be performed.The od of the medium section and the proximal section were within specification.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The target lesion was located in the calcified tibial vessels.A savion flx guide wire was advanced to cross the lesion and then switched out to treat with a non-boston scientific atherectomy device using a non-boston scientific guidewire.The savion crossed well the first two vessels.Before placing it back into patient's body for the third vessel, the physician straightened the tip with his finger and the tip of the wire fell off.The procedure was completed with another savion wire.No patient complications were reported and the patient's status was doing well.It was further reported that the tip fragment broke outside the patient.No piece of the wire broke inside the patient and the patient is doing well.

• 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: 10791896
• Report Number: 2134265-2020-15246
• Device Sequence Number: 16428676
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K180726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 08/18/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025880802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1