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	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt in the non-tortuous and moderately calcified brachial vein.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during first inflation at 18 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with different device.No patient complications were reported and the patient condition was good.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt in the non-tortuous and moderately calcified brachial vein.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during first inflation at 18 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with different device.No patient complications were reported and the patient condition was good.
Additional Manufacturer Narrative
E1 initial reporter address (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.A longitudinal tear was identified in the balloon material.The tear measured 6mm in length and extended from a position 3mm distal of the proximal markerband to 2mm proximal of the proximal markerband.The rated burst pressure for this balloon is 15 atmospheres as per symmetry specification.A visual and tactile examination identified no damage or issues with the shaft of the device.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.This concludes the product analysis.

• 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: 15040106
• Report Number: 2124215-2022-26036
• Device Sequence Number: 6943899
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 05/17/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029421126
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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