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

Lot Number	0031699086
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via facility medwatch #(b)(4) that catheter entrapment on guidewire and shaft break occurred.A 4.50 x 20mm synergy xd drug eluting stent was advanced for treatment.However, during removal, the balloon got stuck on the wire and could not be removed.It was also noticed that the balloon shaft snapped and broke.The balloon was pulled together with the wire.The procedure was completed with the original device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 4.50 x 20mm, catheter was returned for analysis.A visual and tactile examination identified multiple kinking along the length of the hypotube.A visual examination of the distal extrusion identified a break in the midshaft extrusion.The break was located at 22mm proximal from the port site.The extrusion exhibited signs of stretching at the break site as the midshaft was stretched down at the location of the break.Further analysis identified multiple kinking along the hypotube shaft.A microscopic examination of the balloon noted that the balloon exhibited signs of having inflated and was not refolded.The stent had been deployed from the balloon and was not received with the balloon catheter.It was not possible to pass a 0.014 inch size wire through the wire lumen, due the distal extrusion being stretched.
Event or Problem Description
It was reported via facility medwatch #(b)(4) that catheter entrapment on guidewire and shaft break occurred.A 4.50 x 20mm synergy xd drug eluting stent was advanced for treatment.However, during removal, the balloon got stuck on the wire and could not be removed.It was also noticed that the balloon shaft snapped and broke.The balloon was pulled together with the wire.The procedure was completed with the original device.There were no patient complications 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: 17962218
• Report Number: 2124215-2023-57697
• Device Sequence Number: 6715205
• Product Code: NIQ
• UDI-Device Identifier: 08714729981206
• UDI-Public: 08714729981206
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 05/15/2025
• Device Lot Number: 0031699086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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 Age: 85 YR
• Patient Sex: Female