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

Model Number	23295
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located on the moderately tortuous and mildly calcified forearm cephalic vein.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilation.During procedure, the balloon ruptured on the first inflation at 15 atmospheres for 30 seconds.The device was removed without any problem and it was noted that the rupture was vertically separated.The device was replaced for another of the same model to complete the procedure.No complications reported, and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: symmetry balloon was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located within the distal balloon sleeve 1mm proximal from the proximal markerband.The rated burst pressure for this device is 15 atmospheres as per symmetry product specification.A visual and tactile examination identified no damage or issues with the shaft, or tip of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located on the moderately tortuous and mildly calcified forearm cephalic vein.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilation.During procedure, the balloon ruptured on the first inflation at 15 atmospheres for 30 seconds.The device was removed without any problem and it was noted that the rupture was vertically separated.The device was replaced for another of the same model to complete the procedure.No complications reported, and patient status was stable.

• 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: 19055827
• Report Number: 2124215-2024-20934
• Device Sequence Number: 20874855
• 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): 04/26/2024

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 Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0032800018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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