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	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in a shunt in a mildly tortuous and mildly calcified vessel in the forearm.An sv/4.0-4/4t/90 symmetry balloon catheter was advanced for dilatation; however, during the first inflation at 6 atmospheres for 30 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient injuries reported and the patient was in condition good post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: sv/4.0-4/4t/90 was received for analysis.A visual examination identified inflation media within the balloon which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be exiting from the tip of the device.An examination of the balloon material and markerbands identified no issues.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks to the shaft of the device.A leak test identified liquid exiting the tip of the device which is an indication of a breach between the guidewire lumen and the inflation lumen.It is not possible to identify the exact location of the lumen breach.This type of damage is consistent with excessive force being applied when loading the device on to the guidewire.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in a shunt in a mildly tortuous and mildly calcified vessel in the forearm.An sv/4.0-4/4t/90 symmetry balloon catheter was advanced for dilatation; however, during the first inflation at 6 atmospheres for 30 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient injuries reported and the patient was in condition good 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: 17857910
• Report Number: 2124215-2023-53894
• Device Sequence Number: 5930041
• Product Code: LIT
• UDI-Device Identifier: 08714729181798
• UDI-Public: 08714729181798
• 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): 11/06/2023

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: 06/19/2026
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0031851884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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