MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Symmetry?; catheter, angioplasty, peripheral, transluminal

Model Number	M001103270
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately calcified vessel.A symmetry balloon catheter was advanced for dilation.During the second inflation at 16 atmospheres for 10 seconds, the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: device technical analysis upon receipt at our post market quality assurance laboratory, a visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.The returned device was attached to an inflation unit and positive pressure was applied; a pinhole leak was noted at 5mm proximal of the distal sleeve bond.As per the device label specification, the rated burst pressure (rbp) for this device is 15 atmospheres (atm).A visual and tactile examination identified no issues with the tip of the device and with the shaft of the device.No other issues were identified during the product analysis.Device history record (dhr) review review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review a review of the symmetry device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of failure to follow instructions.

• 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 ; +1(763)494-1632
• MDR Report Key: 50209653
• Report Number: 2124215-2026-42903
• Device Sequence Number: 10019046
• Product Code: LIT
• UDI-Device Identifier: 08714729181798
• UDI-Public: (01)08714729181798(17)260918(10)32456479
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 09/18/2026
• Device Model Number: M001103270
• Device Catalogue Number: M001103270
• Device Lot Number: 0032456479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 09/19/2023
• 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