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

Lot Number	0031209042
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign material was present on the device.A 3.00 x 32mm synergy xd drug -eluting stent was selected for use.However, when the package was opened and inspected, grit on the catheter was noted.The procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a synergy xd mr us 3.00 x 32mm was returned for analysis.A visual, tactile and microscopic examination along with a dimensional test was performed.Device analysis could not identify any foreign material attached to the device consistent with the reported "grit".Although blood was visible on the hub/manifold, it is likely that this occurred during the initial handling of the device, during the intended procedure.Further analysis identified that some stent struts were lifted around the mid-body of the balloon and it was identified that the distal tip end of the device was compressed.The reported event of foreign material was not confirmed.
Event or Problem Description
It was reported that foreign material was present on the device.A 3.00 x 32mm synergy xd drug -eluting stent was selected for use.However, when the package was opened and inspected, grit on the catheter was noted.The procedure was completed using an alternate device.No patient complications were reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17644077
• Report Number: 2124215-2023-44205
• Device Sequence Number: 7978803
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: 08714729981008
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: 03/05/2025
• Device Lot Number: 0031209042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown