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

Model Number H7493941808250

Device Problem Break (1069)

Patient Problem Anxiety (2328)

Event Date 05/19/2021

Event Type  Injury  

Event 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
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12021600
• MDR Text Key: 257214411
• Report Number: 2134265-2021-07742
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980780
• UDI-Public: 08714729980780
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: H7493941808250
• Device Lot Number: 0026325913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other