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	Foreign Body In Patient (2687)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The patient presented with chronic critical limb ischemia (cli).The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified pedal vessels.A 300 cm savion flx guidewire was inserted to the lesion.However, the guidewire tip curled up in the occluded segment and it was noticed that the tip broke off.Coyote balloon was being used as a catheter.The wire was removed but the tip was left in a very small occluded segment.The procedure was completed with non-bsc device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Unit returned with its original pouch overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn and lot provided by the customer.The guidewire was inspected, and it was noticed that the polymer jacket was detached at the very tip and not returned confirmed, also, the distal tip was found bent.The device was measured in three sections (distal - medium - proximal) and were within specification.
Event or Problem Description
It was reported that tip detachment occurred.The patient presented with chronic critical limb ischemia (cli).The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified pedal vessels.A 300 cm savion flx guidewire was inserted to the lesion.However, the guidewire tip curled up in the occluded segment and it was noticed that the tip broke off.Coyote balloon was being used as a catheter.The wire was removed but the tip was left in a very small occluded segment.The procedure was completed with non-bsc device.No patient complications were 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: 12197184
• Report Number: 2134265-2021-09260
• Device Sequence Number: 11660294
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 08/25/2021

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: 02/15/2023
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0026811647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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: Other