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

Model Number	H7493941820450
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the cardiac percutaneous coronary intervention (pci) procedure, the stent balloon, emerge monorail balloon (2.5mm x 15mm), lot # 32767500, expiration 7/3/2026, broke off from its deployment shaft, after its successful stent deployment.The balloon broke off while being removed from the patient, and remained seated inside the guiding catheter.After observing the partially broken shaft, the balloon was visualized in the guiding catheter using fluoroscopy and was promptly removed.Second synergy xd drug-eluting system was used (31990123) to complete the procedure.

• Brand Name: SYNERGY¿ XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 19574225
• Report Number: 19574225
• Device Sequence Number: 3980647
• Product Code: NIQ
• UDI-Device Identifier: 08714729981206
• UDI-Public: (01)08714729981206
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/18/2024
• Report Date (Section F): 03/18/2024

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 Model Number: H7493941820450
• Device Catalogue Number: H7493941820450
• Device Lot Number: 32322982
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Date Report Sent to FDA: 03/18/2024