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	07/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion were all anastomotic lesions in the same patient located in the moderately tortuous and severely calcified forearm loop shunt.A total of four symmetry balloon catheters were used in this procedure with two in the sizes 3.5-4/4t/90 and two 3.0-4/4t/90.As the 3.5-40 did not widen, they were changed to 3.0-40 and an attempt was made to increase the pressure, but it also did not widen.During the procedure, the balloons ruptured starting with the first device on the second inflation at 10 atmospheres, the second device on the first inflation at 10 atmospheres, the third device on the first inflation at 8 atmospheres, and the fourth device on the first inflation at 10 atmospheres.All four balloons were inflated for 30 seconds before they burst.The devices were successfully removed with the ruptures noted to be vertically separated in shape before they were replaced for another of the same model to complete the procedure.No complications reported, and patient status was good.

• 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: 19977355
• Report Number: 2124215-2024-50152
• Device Sequence Number: 7075304
• 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
• Report Date (Section B): 08/13/2024

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 Expiration Date: 05/17/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029421129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/13/2024
• 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