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	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 50's.
Event or Problem Description
It was reported that the distal tip of the guidewire detached.The 100% stenosed target lesion was located in the tortuous and severe calcified anterior tibial artery.A savion flx guidewire was selected for a peripheral intervention.The guidewire was inserted into the patient with a subtotaled anterior with severe calcium, access with a 45cm sheath that went up and over the iliac to the contralateral superficial femoral artery (sfa).During the procedure, the tip of the guidewire became separated in a part of the anterior vessel where the calcium was severe.The detached tip of the guidewire was not recovered and was left in the patient due to the vessel was already a subtotaled and did have disease where there was occluded.The procedure was abandoned.The patient was in stable condition and there was no negative sequelae.
Event or Problem Description
It was reported that the distal tip of the guidewire detached.The 100% stenosed target lesion was located in the tortuous and severe calcified anterior tibial artery.A savion flx guidewire was selected for a peripheral intervention.The guidewire was inserted into the patient with a subtotaled anterior with severe calcium, access with a 45cm sheath that went up and over the iliac to the contralateral superficial femoral artery (sfa).During the procedure, the tip of the guidewire became separated in a part of the anterior vessel where the calcium was severe.The detached tip of the guidewire was not recovered and was left in the patient due to the vessel was already a subtotaled and did have disease where there was occluded.The procedure was abandoned.The patient was in stable condition and there was no negative sequelae.
Additional Manufacturer Narrative
A2: age at time of event: 50's.Device evaluated by manufacturer: the returned product consisted of a savion flx guidewire.The visual inspection revealed that the guidewire distal tip was bent.During the microscope 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 at 117.5 inches from the proximal end.The overall length dimensional test could not be performed due to the polymer jacket detachment.The outer diameter (od) of the distal tip, middle section and proximal section were within specification.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 10471714
• Report Number: 2134265-2020-11966
• Device Sequence Number: 2751086
• 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): 10/09/2020

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: 03/07/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025323207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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: Other