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

Model Number	H7493941808250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred and the patient experienced anxiety.A 2.50 x 8mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the catheter cracked/fractured.The device was removed by pulling out and the procedure was completed with another of same device.It was also reported that the patient experienced anxiety.No further patient complications were reported and the patient has fully recovered.

• 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: 12021600
• Report Number: 2134265-2021-07742
• Device Sequence Number: 3197181
• Product Code: NIQ
• UDI-Device Identifier: 08714729980780
• UDI-Public: 08714729980780
• Combination Product (Y/N): Y
• Initial Reporter State: DE
• 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): 06/17/2021

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: 10/29/2022
• Device Model Number: H7493941808250
• Device Lot Number: 0026325913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/17/2021
• 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