MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT

Model Number	H7493941808350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 8mm synergy xd drug-eluting stent was selected to use.However, during insertion, the physician broke the shaft of the stent 6 inches from the hub outside the patient's body.The procedure was completed with another of same device.No patient complications were reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11815558
• Report Number: 2134265-2021-06243
• Device Sequence Number: 11568942
• Product Code: NIQ
• UDI-Device Identifier: 08714729981022
• UDI-Public: 08714729981022
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: H7493941808350
• Device Lot Number: 0026429596
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1