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 Code Available (3191)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the tip of the guidewire detached inside a patient during a procedure.The 70-80% stenosed target lesion was located in the moderately tortuous and moderately calcified pedal arch.A savion flx guidewire was selected for use.The guidewire was successfully prepped and a 2x40 coyote balloon was advanced over the wire without issue.The wire and the balloon were advanced into the pedal arch.The wire was always out in front of the balloon while advancing.During removal of the balloon over the wire, the tip of the wire had detached in the distal lateral plantar artery.The tip of the wire was removed from the patient with a snare.The procedure was completed with a good result and there were no patient complications.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the guidewire and a 0.5 inch section of the detached polymer jacket distal tip were returned with its original pouch.A review of media revealed the label was in good condition.No damages were observed on the pouch surface.A visual inspection of the returned device found the detached section was located approximately at 117.7 inches from the proximal end.No more visual damages were found in the device.The overall length did not meet dimensional specification.
Event or Problem Description
It was reported that the tip of the guidewire detached inside a patient during a procedure.The 70-80% stenosed target lesion was located in the moderately tortuous and moderately calcified pedal arch.A savion flx guidewire was selected for use.The guidewire was successfully prepped and a 2x40 coyote balloon was advanced over the wire without issue.The wire and the balloon were advanced into the pedal arch.The wire was always out in front of the balloon while advancing.During removal of the balloon over the wire, the tip of the wire had detached in the distal lateral plantar artery.The tip of the wire was removed from the patient with a snare.The procedure was completed with a good result and there were no patient complications.

• 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: 10448912
• Report Number: 2134265-2020-11580
• Device Sequence Number: 19662209
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/24/2020

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: 07/07/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025683348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention