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

Model Number	1006
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip detached.A savion flx was selected for a procedure in the calcified dorsalis pedis of the left foot.The wire was attempted to cross through the calcified lesion.Upon attempting to withdraw the wire, the tip became stuck in the calcium.When the device was pulled to remove from the lesion, the tip detached.The detached tip was removed with a snare and the procedure was aborted.There were no further patient complications and the patient was fine.
Additional Manufacturer Narrative
Device eval by manufacturer: visual examination of the returned guidewire revealed a bent distal tip.The body of the guidewire was kinked at approximately 0.5 inches and 54 inches from the proximal end.No other visual damages were found on the device.Microscopic examination revealed that the polymer jacket's distal end had a detached section that was not returned.The core wire also protruded from the polymer jacket end.Dimensional inspection revealed that the outer diameter (od) of the distal tip, the od of the middle of the device, and the od of the proximal section were all within specification.Overall length could not be measured due to the polymer jacket detachment.The detached section of the polymer jacket was located approximately 117.5 inches from the proximal end.
Event or Problem Description
It was reported that the tip detached.A savion flx was selected for a procedure in the calcified dorsalis pedis of the left foot.The wire was attempted to cross through the calcified lesion.Upon attempting to withdraw the wire, the tip became stuck in the calcium.When the device was pulled to remove from the lesion, the tip detached.The detached tip was removed with a snare and the procedure was aborted.There were no further patient complications and the patient was fine.It was further reported that the anatomy was mildly tortuous, and the lesion was a 100% chronic total occlusion with severe calcification.

• 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: 10456684
• Report Number: 2134265-2020-11783
• Device Sequence Number: 3524840
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/10/2020

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: 06/02/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025555298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR