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

Model Number	23295
Medical Device Problem Codes	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	08/20/2024
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 tortuous and non-calcified cephalic vein of the forearm.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilation.During the procedure, the balloon ruptured in a vertical form upon third inflation at 15 atmospheres for 30 seconds.The device was removed without any problems, and the procedure was completed with another of the same device.No complications were reported, and the patient was in good condition after the procedure.
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 complete balloon circumferential tear was identified located at the proximal markerband.The rated burst pressure for this balloon is 15 atmospheres as per specification.A visual and tactile examination found the shaft of the device to be severely stretched between the proximal and distal markerbands.The shaft was also kinked at the distal tip bond.A complete separation of the shaft was also identified located approximately 210mm proximal of the proximal balloon bond.The site of separation displayed evidence of being cut, possibly to facilitate the removal of the hub/manifold during removal of the device from the patient.A visual and tactile examination found no issues with the tip of the device.A visual and tactile examination found no issues with the markerbands of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and non-calcified cephalic vein of the forearm.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilation.During the procedure, the balloon ruptured in a vertical form upon third inflation at 15 atmospheres for 30 seconds.The device was removed without any problems, and the procedure was completed with another of the same device.No complications were reported, and the patient was in good condition after the 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: 20186384
• Report Number: 2124215-2024-56589
• Device Sequence Number: 17893302
• Product Code: LIT
• UDI-Device Identifier: 08714729181736
• UDI-Public: 08714729181736
• 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): 10/07/2024

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: 05/16/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029413718
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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