MAUDE Adverse Event Report: SIS MEDICAL AG OPN NC; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	350-015-004
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A ballon was inserted over the wire during a coronary intervention.The portion of the balloon shaft that was outside the patient's body broke.The balloon was removed and not used.All portions of the balloon were accounted for.

• Brand Name: OPN NC
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): SIS MEDICAL AG; 1783 forest drive; no. 254; annapolis MD 21401
• MDR Report Key: 23476430
• Report Number: 23476430
• Device Sequence Number: 18699263
• Product Code: LOX
• UDI-Device Identifier: 07640142570608
• UDI-Public: (01)07640142570608
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/13/2025
• Report Date (Section F): 10/13/2025

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 Model Number: 350-015-004
• Device Lot Number: 216954
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/13/2025