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 Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the guidewire detached inside a patient during a procedure.A savion flx guidewire was selected for a procedure.While working in the distal posterior artery, which was roughly 2.5mm and occluded, the tip of the guidewire detached inside the patient.The physician was able to retrieve the guidewire fragment with a snare wire.There were no patient complications reported.
Event or Problem Description
It was reported that the tip of the guidewire detached inside a patient during a procedure.A savion flx guidewire was selected for a procedure.While working in the distal posterior artery, which was roughly 2.5mm and occluded, the tip of the guidewire detached inside the patient.The physician was able to retrieve the guidewire fragment with a snare wire.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the guidewire was returned together with its original opened pouch.The returned guidewire had the distal tip bent.The polymer jacket distal end was detached and it was not returned.The detached section was located approximately at 298.4 cm from the proximal end.The bent section found in the distal tip was located approximately at 296 cm from the proximal end.No more visual damages were found in the device.Upon microscopic inspection, detailed pictures of the affected area were captured.Dimensional inspection revealed that the overall length could not be performed due to device condition (polymer jacket distal end detached).The outer diameter (od) of the distal tip could not be performed due to device condition (polymer jacket distal end detached).The od of middle of the device was within specification.The od of the proximal section was 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: 10139348
• Report Number: 2134265-2020-07789
• Device Sequence Number: 16749260
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/18/2020

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: 02/04/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025165428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention