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

Model Number	23295
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: sv/5.5-4/4t/90 was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A leak test identified a balloon pinhole located at the proximal edge of the proximal balloon cone.An examination of the balloon material and markerbands identified no other issues.The rated burst pressure for this balloon is 15 atmospheres as per symmetry specification.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination identified no issues with the tip of the device.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that balloon leak was encountered.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified arteriovenous fistula vein side.A 5.5-4/4t/90 symmetry balloon catheter was advanced for dilation but when an inflation device was attached and pressurization was performed, the pressure did not increase.The device was removed from the patient body and checked; thus, it was noted that the inflation solution was leaking from the middle of the shaft.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed balloon pinhole.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16807778
• Report Number: 2124215-2023-18847
• Device Sequence Number: 14960888
• Product Code: LIT
• UDI-Device Identifier: 08714729181934
• UDI-Public: 08714729181934
• 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
• Report Date (Section B): 04/25/2023

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: 05/22/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029449425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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