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

Model Number	H7493926020350
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the case, doctors were introducing the stent and it broke off as it was going in.Fortunately it was before it reached the artery and was able to easily be removed, we then opened another stent and proceeded on, there was a short delay.

• Brand Name: SYNERGY¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8270247
• Report Number: 8270247
• Device Sequence Number: 11125026
• Product Code: NIQ
• UDI-Device Identifier: 08714729840183
• UDI-Public: (01)08714729840183(17)200626(10)22343407
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/14/2018
• Report Date (Section F): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493926020350
• Device Catalogue Number: H7493926020350
• Device Lot Number: 22343407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/14/2018