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	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the 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 longitudinal tear was identified beginning at the distal balloon bond and extending approximately 20mm proximally across the balloon material.The rated burst pressure for this balloon is 15 atmospheres.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found no damage to the 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.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the shunt vein.A symmetry balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 10 atmospheres for 30 seconds.The device was removed without any problem, and the procedure was completed with a different device.No complications were reported, and the patient was in good condition after the 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21279768
• Report Number: 2124215-2025-04865
• Device Sequence Number: 7831274
• Product Code: LIT
• UDI-Device Identifier: 08714729182757
• UDI-Public: 08714729182757
• 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
• Report Date (Section B): 01/30/2025

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: 0031709528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER - TRAIN; INTRODUCER SHEATH - 6F SHEATH
• Patient Sex: Unknown