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

Model Number	1006
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month it was reported, no information was provided.
Event or Problem Description
It was reported that the tip of the guidewire detached inside a patient during a procedure.A savion flx guidewire was selected for a procedure.The guidewire was inserted through a 0.018" rubicon support catheter.While working on a popliteal occlusion, the physician was unable to cross the lesion.While attempting to exchange the guidewire for a different one, the tip detached inside the patient in the popliteal.The case was aborted.There were no patient complications reported.
Event or Problem Description
It was reported that the tip of the guidewire detached inside a patient during a procedure.A savion flx guidewire was selected for a procedure.The guidewire was inserted through a 0.018" rubicon support catheter.While working on a popliteal occlusion, the physician was unable to cross the lesion.While attempting to exchange the guidewire for a different one, the tip detached inside the patient in the popliteal.The case was aborted.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the guidewire was returned together with its original opened pouch.The distal tip was bent/kinked.The distal end of the polymer jacket was detached, and it was not returned.The detached section of the polymer jacket was located approximately at 298.4 cm from the proximal end.The core wire was not complete; it had a detached section, which was not returned.The core wire measured approximately 298.5 cm from the proximal end.No other visual damages were observed.Dimensional inspection revealed that the overall length could not be performed due to device condition (polymer tip and core wire detached).The outer diameter (od) of the distal tip could not be performed due to device condition (polymer tip and core wire detached).The od of the middle of the device was within specification.The od of the proximal section was within specification.B3 date of event: used the first date of the month it was reported, no information was provided.

• 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: 10148219
• Report Number: 2134265-2020-07895
• Device Sequence Number: 2176823
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 03/24/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025401239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/02/2020
• 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