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

Model Number	23295
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 device was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied; the balloon was inflated to its rate of burst pressure and a balloon pinhole leak on the surface of the distal balloon sleeve was identified.No other issues were identified with balloon inflation or the balloon material.No issues were identified with the tip of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from damage.No issues were noted which may have potentially contributed to the complaint incident.
Event or Problem Description
Reportable based on device analysis completed on 05-nov-2021.It was reported that tip leak and balloon inflation failure occurred.The 95% stenosed target lesion was located in an arteriovenous fistula in a mildly tortuous and mildly calcified vein side.A /6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation; however, during the first inflation, it was noticed thru fluoroscopy that the radiopaque substance was leaking near the tip part of the balloon and the pressure was unable to be applied.The procedure was completed with a different device.There were no patient injuries reported.However, returned device analysis revealed balloon pinhole.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12807257
• Report Number: 2134265-2021-14179
• Device Sequence Number: 20211603
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 05/10/2024
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0027290206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown