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

Model Number	1006
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The chronic totally occluded target lesion with moderate to severe calcification was located in the moderately tortuous anterior tibial artery (ata).The vessel was very diseased and had several occlusions down the vessel before refilling close to the foot.A savion flx guidewire was prepped and advanced through a 2.6f non-bsc support catheter.Within a minute, the tip of the guidewire broke off approximately halfway down the ata and became lodged in situ.The remainder of the savion flx guidewire was removed, and then a non-bsc guidewire was used without issue.The case was abandoned.The patient was stable.An attempt will be made again should the blood flow to the toe amputation wound site not be sufficient.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluation by mfr: the customer provided pictures related to the complaint and a media review was performed.The pictures show an x-ray with the distal tip of the wire, detached.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The chronic totally occluded target lesion with moderate to severe calcification was located in the moderately tortuous anterior tibial artery (ata).The vessel was very diseased and had several occlusions down the vessel before refilling close to the foot.A savion flx guidewire was prepped and advanced through a 2.6f non-bsc support catheter.Within a minute, the tip of the guidewire broke off approximately halfway down the ata and became lodged in situ.The remainder of the savion flx guidewire was removed, and then a non-bsc guidewire was used without issue.The case was abandoned.The patient was stable.An attempt will be made again should the blood flow to the toe amputation wound site not be sufficient.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluation by mfr: unit returned with its original box.The unit returned has the tip damaged, as part of overall visual revision.The returned guidewire had the distal tip bent with a section of the core wire exposed due to the detached polymer jacket.Upon microscope inspection it was confirmed the that the guidewire had the distal tip bent with a section of the core wire exposed due to the detached polymer jacket.The device was measured in three sections (distal - medium - proximal) and was within specification.Overall length could not be measured due to detachment condition.The customer has provided a picture related to the complaint, where is possible to observe an x-ray photo with the wire distal tip section detached.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The chronic totally occluded target lesion with moderate to severe calcification was located in the moderately tortuous anterior tibial artery (ata).The vessel was very diseased and had several occlusions down the vessel before refilling close to the foot.A savion flx guidewire was prepped and advanced through a 2.6f non-bsc support catheter.Within a minute, the tip of the guidewire broke off approximately halfway down the ata and became lodged in situ.The remainder of the savion flx guidewire was removed, and then a non-bsc guidewire was used without issue.The case was abandoned.The patient was stable.An attempt will be made again should the blood flow to the toe amputation wound site not be sufficient.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: 11828352
• Report Number: 2134265-2021-05631
• Device Sequence Number: 4015586
• Product Code: DQX
• UDI-Device Identifier: 08714729978831
• UDI-Public: 08714729978831
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2021

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: 05/28/2021
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0023870558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 05/17/2021; 06/16/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/10/2021; 07/01/2021
• 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