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

Model Number	1006
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon system became stuck on the guidewire.A savion flx guidewire was selected for use along with a 2x40x144 coyote es 2x40x144 balloon catheter for a tibial intervention procedure in the right posterior tibial artery.During the procedure, the wire was unable to be pulled from the catheter.It was reported that there was material from towels nearby accumulating on the savion flx wire which created a sticking point on the wire.The wire and balloon system were removed together from the patient body, and the wire was removed from the proximal end of the balloon instead of from the hub.The procedure was completed with another of the same balloon device and a new wire.No patient complications were reported.
Event or Problem Description
It was reported that the balloon system became stuck on the guidewire.A savion flx guidewire was selected for use along with a 2x40x144 coyote es 2x40x144 balloon catheter for a tibial intervention procedure in the right posterior tibial artery.During the procedure, the wire was unable to be pulled from the catheter.It was reported that there was material from towels nearby accumulating on the savion flx wire which created a sticking point on the wire.The wire and balloon system were removed together from the patient body, and the wire was removed from the proximal end of the balloon instead of from the hub.The procedure was completed with another of the same balloon device and a new wire.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The returned guidewire had the body kinked approximately at 85 cm and 299.3 cm from the proximal end.The distal tip was kinked approximately at 0.5 cm from the distal end.No more visual damages were found in the device.The dimensional inspection of the overall length, the distal tip outer diameter (od), the middle section od, and the proximal section od were all 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: 10020899
• Report Number: 2134265-2020-05923
• Device Sequence Number: 11411193
• 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): 07/08/2020

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: 01/23/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025098085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 07/08/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COYOTE ES 2X40X144 BALLOON; COYOTE ES 2X40X144 BALLOON
• Patient Age: 82 YR