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

Model Number	H7493941820500
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch (b)(4) that balloon rupture occurred.A 5.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, it was noted that the balloon from the stent was ruptured.Then the fracture of the balloon shaft while delivering the second stent required trapping and snaring of the stent to removed from the body.The procedure was completed and there were no patient complications reported.No patient harmed.
Additional Manufacturer Narrative
B3: date of event: used first date of the month since event date was not provided.

• 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: 21102266
• Report Number: 2124215-2024-82855
• Device Sequence Number: 8818565
• Product Code: NIQ
• UDI-Device Identifier: 08714729981268
• UDI-Public: 08714729981268
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: 07/01/2026
• Device Model Number: H7493941820500
• Device Catalogue Number: H7493941820500
• Device Lot Number: 0034452976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/08/2025
• Date Device Manufactured: 07/01/2024
• 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: 67 YR
• Patient Sex: Unknown