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	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
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 shunt blood vessel.A 4.0-4/4t/90 symmetry balloon catheter was advanced for dilatation, however, during the procedure the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr: a symmetry 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.The balloon was attached to an encore inflation device, subjected to positive pressure and no issues or leaks were noted with the balloon.The rated burst pressure for this device is 15 atmospheres as per symmetry product specification.The balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a shaft pinhole located proximal of the proximal balloon bond.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.
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 shunt blood vessel.A 4.0-4/4t/90 symmetry balloon catheter was advanced for dilatation, however, during the procedure the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported.It was further reported that the balloon ruptured during the second inflation at 15 atmospheres for 30 seconds.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).
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 shunt blood vessel.A 4.0-4/4t/90 symmetry balloon catheter was advanced for dilatation, however, during the procedure the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported.It was further reported that the balloon ruptured during the second inflation at 15 atmospheres for 30 seconds.

• 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: 16350694
• Report Number: 2124215-2023-05762
• Device Sequence Number: 6318692
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2023

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: 05/26/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029484594
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 02/12/2023; 03/06/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 02/22/2023; 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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