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

Model Number	M001105200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: symmetry device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A partial circumferential tear was identified in the balloon material approximately 7mm proximal from the distal markerband.The rated burst pressure for this balloon is 15 atmospheres.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.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified cephalic vein of the forearm.A 4.0-10/4t/90 symmetry? stiff shaft balloon catheter was advanced for dilatation.However, during first inflation at 8 atmospheres for 30 seconds, the balloon vertically ruptured.The device was removed, and the procedure was completed with another of the same device.No patient injuries reported, and the patient condition was good post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified cephalic vein of the forearm.A 4.0-10/4t/90 symmetry? stiff shaft balloon catheter was advanced for dilatation.However, during first inflation at 8 atmospheres for 30 seconds, the balloon vertically ruptured.The device was removed, and the procedure was completed with another of the same device.No patient injuries reported, and the patient condition was good post-procedure.

• Brand Name: SYMMETRY? STIFF SHAFT
• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22523183
• Report Number: 2124215-2025-42641
• Device Sequence Number: 8633356
• Product Code: LIT
• UDI-Device Identifier: 08714729182757
• UDI-Public: (01)08714729182757(17)260528(10)31709529
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060959
• 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): 08/19/2025

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: 05/28/2026
• Device Model Number: M001105200
• Device Catalogue Number: M001105200
• Device Lot Number: 0031709529
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• 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 Sex: Unknown