MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	23295
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified vessel in the left elbow.A 5.5-40/4t/90 symmetry balloon catheter was advanced for dilation.During the first inflation at 10 atmospheres, the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified vessel in the left elbow.A 5.5-40/4t/90 symmetry balloon catheter was advanced for dilation.During the first inflation at 10 atmospheres, the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).Device evaluated by mfr: the symmetry device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A partial balloon circumferential tear was identified located approximately 6mm distal of the distal markerband.The rated burst pressure for this device is 15 atmospheres as per symmetry product specification.A visual and tactile examination identified no damage or issues with the shaft of the device.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: SYMMETRY
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; la aurora - heredia 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23716950
• Report Number: 2124215-2025-89188
• Device Sequence Number: 8845972
• Product Code: LIT
• UDI-Device Identifier: 08714729181934
• UDI-Public: (01)08714729181934
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: 23295
• Device Catalogue Number: 23295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER-SYMMETRY; BALLOON CATHETER-SYMMETRY; GUIDEWIRE-GT16; GUIDEWIRE-GT16; INFLATION DEVICE-GM30; INFLATION DEVICE-GM30; INTRODUCER SHEATH-MEDIKIT; INTRODUCER SHEATH-MEDIKIT
• Patient Sex: Unknown