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	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the guidewire detached.A savion flx guidewire was selected for use.During the procedure while attempting to cross severe calcified lesion of the right common plantar artery of the foot, the savion wire's tip detached.Gross manipulation of the wire tip was used while attempting to cross lesion.This was unsuccessful and as the wire was removed through the coyote balloon, the tip detached.Due to chronic total occlusion (cto) of that area, the broken tip was left in the patient.The procedure was completed with a different device.There were no further patient complications reported and the patient condition is okay.
Event or Problem Description
It was reported that the tip of the guidewire detached.A savion flx guidewire was selected for use.During the procedure while attempting to cross severe calcified lesion of the right common plantar artery of the foot, the savion wire's tip detached.Gross manipulation of the wire tip was used while attempting to cross lesion.This was unsuccessful and as the wire was removed through the coyote balloon, the tip detached.Due to chronic total occlusion (cto) of that area, the broken tip was left in the patient.The procedure was completed with a different device.There were no further patient complications reported and the patient condition is okay.
Additional Manufacturer Narrative
Device analysis by mfr: the returned guidewire had the distal tip bent.Its body was kinked approximately at 0.75 inches from the proximal end.No further visual damages was found in the device.During the inspection it was encountered that the polymer jacket distal end had a detached section and it was not returned.The core wire protruded from the polymer jacket end.The detached section was located approximately (started at) at 117.7 inches from the proximal end.Dimensional inspection revealed that the overall length did not meet specification due to the polymer jacket detached.The distal tip outer diameter (od), the middle section od and the proximal section od were within specification.

• 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: 10460327
• Report Number: 2134265-2020-11793
• Device Sequence Number: 2939770
• 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): 09/28/2020

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: 07/18/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025736442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR