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

Model Number	M001103300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a severely tortuous and non-calcified radial antecubital vein.A 4.5-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during the initial inflation at 10 atmospheres for one minute, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: upon receipt at our post market quality assurance laboratory, this symmetry device was examined.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon was attached to an inflation device, subjected to positive pressure and liquid was observed to be leaking from the distal balloon bond, approximately 2mm proximal from the distal tip, which confirms the event.The rated burst pressure for this device is 15 atmospheres as per symmetry product specification.No other issues were identified during the product analysis.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the symmetry device confirmed that the event of balloon- material rupture was known events defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion: based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as adverse event related to patient condition.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a severely tortuous and non-calcified radial antecubital vein.A 4.5-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during the initial inflation at 10 atmospheres for one minute, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient complications as a result of this event.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24108173
• Report Number: 2124215-2026-03362
• Device Sequence Number: 21276218
• Product Code: LIT
• UDI-Device Identifier: 08714729181859
• UDI-Public: (01)08714729181859(17)260626(10)31902262
• 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): 04/08/2026

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 Expiration Date: 06/26/2026
• Device Model Number: M001103300
• Device Catalogue Number: M001103300
• Device Lot Number: 0031902262
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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