MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	23295
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).
Event or Problem Description
It was reported that shaft hole occurred.A 6.0-4/4t/90 symmetry balloon catheter was advanced for dilation.During the procedure, the balloon did not properly inflate upon second inflation.After removal, there was a hole noted around the middle shaft.No patient complications were reported.
Event or Problem Description
It was reported that shaft hole occurred.A 6.0-4/4t/90 symmetry balloon catheter was advanced for dilation.During the procedure, the balloon did not properly inflate upon second inflation.After removal, there was a hole noted around the middle shaft.No patient complications were reported.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).Device evaluated by mfr: the 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.No issues were identified with the balloon material.A visual and tactile examination of the shaft identified that it was damaged on several locations on the shaft and is also noted to be severed on one location.The shaft was also noted to have multiple shaft kinks.A visual examination identified no issues with the tip of the device.

• 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: 19660232
• Report Number: 2124215-2024-40842
• Device Sequence Number: 15102069
• Product Code: LIT
• UDI-Device Identifier: 08714729181972
• UDI-Public: 08714729181972
• 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): 08/05/2024

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: 05/12/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029393488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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