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	03/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device separation, unreserved device fragment, and cancelled procedure requiring surgery occurred.The target lesion was located in the tibial peroneal trunk.A savion flx guidewire was advanced; however, upon exiting the guide sheath, it was noticed that a fragment of wire was floating in the artery.It was determined upon fluoroscopy that it was the tip of the wire that had broken off.The wire traveled down the patient's artery in the leg and ended up in the distal posterior tibial artery.The patient is scheduled to have the broken wire fragment removed in two weeks.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned in a generic plastic bag, 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 returned guidewire had the small portion of the polymer jacket detached and it was not returned.The end distal tip was found bent.Polymer jacket detached at very tip and not returned confirmed.The polymer section that could be measured was inspected.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.
Event or Problem Description
It was reported that device separation, unretrieved device fragment, and canceled procedure requiring surgery occurred.The target lesion was located in the tibial peroneal trunk.A savion flx guidewire was advanced; however, upon exiting the guide sheath, it was noticed that a fragment of wire was floating in the artery.It was determined upon fluoroscopy that it was the tip of the wire that had broken off.The wire traveled down the patient's artery in the leg and ended up in the distal posterior tibial artery.The patient is scheduled to have the broken wire fragment removed in two weeks.

• 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: 11615072
• Report Number: 2134265-2021-03989
• Device Sequence Number: 11553356
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 05/10/2021

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: 07/18/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025736442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/10/2021
• 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; Required Intervention
• Patient Age: 77 YR