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	11/29/2022
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 moderately calcified forearm cephalic vein.A 4.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during initial inflation at 16 atmospheres for 30 seconds, the balloon ruptured and vertically separated.The device was removed without any problem, and the procedure was completed with another of same device.There were no patient complications nor injuries, reported and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter address 1: 2 (b)(6).Device evaluated by mfr.: symmetry sv/4.5-4/4t/90 was received for analysis.A visual examination identified that the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied; the balloon was inflated to its rate of burst pressure of 15 atmospheres for 30 seconds using digital timer without issue.A vacuum was then applied.The inflation device was verified at 15 atmospheres, before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 15 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found no damage or issues with shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and moderately calcified forearm cephalic vein.A 4.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during initial inflation at 16 atmospheres for 30 seconds, the balloon ruptured and vertically separated.The device was removed without any problem, and the procedure was completed with another of same device.There were no patient complications nor injuries, reported and the patient was in good condition post-procedure.

• Brand Name: SYMMETRY
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15923589
• Report Number: 2124215-2022-50556
• Device Sequence Number: 14754940
• Product Code: LIT
• UDI-Device Identifier: 08714729181859
• UDI-Public: 08714729181859
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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: 07/18/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029789967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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