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	03/10/2025
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 moderately calcified forearm shunt.A 4.5-4/4t/90 symmetry balloon was advanced for dilation.However, during the second inflation at about 8 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications as a result of this event, and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was noted inside the balloon which is evidence of a device leak.A balloon pinhole in the balloon material was identified located approximately 10mm distal of the proximal markerband.The rated burst pressure for this balloon is 15 atmospheres as per specification.A visual and tactile examination found no kinks or damage to the shaft and tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately calcified forearm shunt.A 4.5-4/4t/90 symmetry balloon was advanced for dilation.However, during the second inflation at about 8 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no patient complications as a result of this event, and the patient was in good condition post-procedure.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21706203
• Report Number: 2124215-2025-18798
• Device Sequence Number: 15955090
• Product Code: LIT
• UDI-Device Identifier: 08714729181859
• UDI-Public: (01)08714729181859(17)260911(10)32407305
• 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): 05/16/2025

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: 09/11/2026
• Device Model Number: M001103300
• Device Catalogue Number: M001103300
• Device Lot Number: 0032407305
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - GT WIRE; GUIDEWIRE - GT WIRE; INTRODUCER SHEATH - 5F SHEATH; INTRODUCER SHEATH - 5F SHEATH
• Patient Sex: Unknown