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	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6)/.
Event or Problem Description
It was reported that the guidewire tip detached inside the patient.A savion flx guidewire was selected for use in the severely calcified and stenosed truncus.During the procedure, the guidewire was able to pass the first part of the stenosis, but it could not be moved further forward.As the physician was trying to pull it back, the tip of the guidewire detached.The guidewire body was removed from patient and the detached tip of the guidewire was left in the totally occluded portion of the lesion.The procedure was completed with another device.The patient experienced no complications and was stable post-procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a savion flx guidewire.The distal tip was bent.The polymer jacket distal end was detached 183.8 cm from the proximal end and it was not returned.The body of the guidewire was kinked approximately at 0.8 cm from the proximal end.No more visual damages were found in the device.Dimensional inspection was completed and the measured outer diameters were found to be within specification.Inspection of the remainder of the device presented no other damage or irregularities.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the guidewire tip detached inside the patient.A savion flx guidewire was selected for use in the severely calcified and stenosed truncus.During the procedure, the guidewire was able to pass the first part of the stenosis, but it could not be moved further forward.As the physician was trying to pull it back, the tip of the guidewire detached.The guidewire body was removed from patient and the detached tip of the guidewire was left in the totally occluded portion of the lesion.The procedure was completed with another device.The patient experienced no complications and was stable post-procedure.

• 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: 10140521
• Report Number: 2134265-2020-07770
• Device Sequence Number: 19358216
• Product Code: DQX
• UDI-Device Identifier: 08714729978848
• UDI-Public: 08714729978848
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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: 06/03/2021
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0023897141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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