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

Model Number	M001103320
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified shunt vessels.A 5.0-4/4t/90 symmetry balloon was selected for use in a vascular access intervention therapy.The symmetry balloon was inflated at the stenotic site.Afterwards, when attempting to pull out the balloon catheter, resistance was encountered, and the balloon rupture occurred at the tip of the non-boston scientific sheath.The shaft and balloon separated; however, the sheath and the ruptured balloon were recovered together with no fragments remaining in the body.The procedure was completed with this device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified shunt vessels.A 5.0-4/4t/90 symmetry balloon was selected for use in a vascular access intervention therapy.The symmetry ballon was inflated at the stenotic site.Afterwards, when attempting to pull out the balloon catheter, resistance was encountered, and the balloon rupture occurred at the tip of the non-boston scientific sheath.The shaft and balloon separated; however, the sheath and the ruptured balloon were recovered together with no fragments remaining in the body.The procedure was completed with this device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned in two sections due to a complete separation of the shaft.A visual examination identified that the balloon had a full circumferential tear approximately 22mm distal from the proximal balloon bond.The distal section of balloon material was not returned for analysis.A visual and tactile examination identified a shaft break.The shaft was noted to be stretched, and multiple kinks was noted along the length of the device.A visual examination identified no issues with the tip of the device.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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23065958
• Report Number: 2124215-2025-62878
• Device Sequence Number: 9866945
• Product Code: LIT
• UDI-Device Identifier: 08714729181897
• UDI-Public: (01)08714729181897(17)260913(10)32423540
• 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): 11/18/2025

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: 09/13/2026
• Device Model Number: M001103320
• Device Catalogue Number: M001103320
• Device Lot Number: 0032423540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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: V-18 BOSTON, V-18 GUIDEWIRE; GUIDEWIRE: V-18 BOSTON, V-18 GUIDEWIRE; INTRODUCER SHEATH: 5F GOOD TECH MOSQUITO; INTRODUCER SHEATH: 5F GOOD TECH MOSQUITO
• Patient Sex: Unknown