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

Model Number	1006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date, as no event date is provided.(b)(6).
Event or Problem Description
It was reported that a guidewire fracture occurred.A savion flx guidewire was used.However, the guidewire detached in the anterior tibial artery (at) while a 2.5 x 220 coyote balloon catheter was being used.A pedal approach was obtained and it attempted to retrieve the wire with a snare.
Additional Manufacturer Narrative
E1 - updated.B2 - outcomes attrib to adv event updated.B3 - date of event updated.B5 - describe event or problem updated.
Event or Problem Description
It was reported that a guidewire fracture occurred.A savion flx guidewire was used.However, the guidewire detached in the anterior tibial artery (at) while a 2.5 x 220 coyote balloon catheter was being used.A pedal approach was obtained and it attempted to retrieve the wire with a snare.It was further reported that vascular access was an antegrade approach via pedal.The target lesion was 78% stenosed and was located in the mildly tortuous and moderately calcified left distal leg posterior tibial artery.The broken wire was successfully snared and removed from the patient.The procedure was completed with another savion guidewire via femoral approach.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the unit returned with the wire broken, as part of overall visual revision.The customer attached a picture of a cardboard box of savion flx; the box showed the lot number matched printed on the label which matched with the lot number reported in this complaint.No visual damages were observed through the image provided.The guidewire returned together with its original opened box.The returned guidewire was received separated in two sections; one of them measured approximately 14.75 inches and 103 inches.The proximal end of the shortest section returned showed a kink that was located approximately at 1 inch from the end.No more visual damages were found in the device.During the inspection the polymer jacket distal end was inspected and no damages were found.
Event or Problem Description
It was reported that a guidewire fracture occurred.A savion flx guidewire was used.However, the guidewire detached in the anterior tibial artery (at) while a 2.5 x 220 coyote balloon catheter was being used.A pedal approach was obtained and it attempted to retrieve the wire with a snare.It was further reported that vascular access was an antegrade approach via pedal.The target lesion was 78% stenosed and was located in the mildly tortuous and moderately calcified left distal leg posterior tibial artery.The broken wire was successfully snared and removed from the patient.The procedure was completed with another savion guidewire via femoral approach.There were no patient complications nor injuries reported.

• 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: 11109058
• Report Number: 2134265-2020-18443
• Device Sequence Number: 11027731
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K180726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2021

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: 11/03/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0026298054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 02/12/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 01/07/2021; 03/08/2021
• 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