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

Model Number	1115
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	06/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the radiopaque tip fell off and remained inside the patient.A savion dlvr was selected for a superficial femoral artery (sfa)-popliteal lower leg angiogram procedure.During the procedure, the physician was trying to get through a lesion in the sfa-popliteal, while using a rubicon device, and the wire shredded.The radiopaque tip of the wire fell off and remained inside the patient.They were unable to retrieve the tip of the wire and it is still inside the patient.The case was aborted.
Additional Manufacturer Narrative
Device evaluated by mfr: the unit was returned with its original pouch.The device has the distal tip kinked and stretched.The polymer distal tip was detached and it was not returned.No other damage was noted on the device.The overall length and the outer diameter (od) of the distal tip could not be performed due to the device condition.The od of the middle of the device and the od of the proximal section were within specification.
Event or Problem Description
It was reported that the radiopaque tip fell off and remained inside the patient.A savion dlvr was selected for a superficial femoral artery (sfa)-popliteal lower leg angiogram procedure.During the procedure, the physician was trying to get through a lesion in the sfa-popliteal, while using a rubicon device, and the wire shredded.The radiopaque tip of the wire fell off and remained inside the patient.They were unable to retrieve the tip of the wire and it is still inside the patient.The case was aborted.

• Brand Name: SAVION DLVR
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8780803
• Report Number: 2134265-2019-08033
• Device Sequence Number: 1845827
• Product Code: DQX
• UDI-Device Identifier: 08714729978862
• UDI-Public: 08714729978862
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 07/31/2020
• Device Model Number: 1115
• Device Catalogue Number: 1115
• Device Lot Number: 0022457824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RUBICON SUPPORTING CATHETER; RUBICON SUPPORTING CATHETER; RUBICON SUPPORTING CATHETER
• Outcome Attributed to Adverse Event: Other