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	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in an arteriovenous shunt in the moderately tortuous vessel.A 6.0-2/4t/90 symmetry balloon catheter was advanced for dilation and was initially inflated at 8 atmospheres (atm) for 1 minute.The second inflation at 10 atmospheres for a minute.However, during the third inflation at 10 atmospheres for 1 minute, the balloon ruptured, the device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient condition was good.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6) e1.Initial reporter city: (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 of 15 atmospheres without any leaks or issues noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip section of the device.A visual 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.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in an arteriovenous shunt in the moderately tortuous vessel.A 6.0-2/4t/90 symmetry balloon catheter was advanced for dilation and was initially inflated at 8 atmospheres (atm) for 1 minute.The second inflation at 10 atmospheres for a minute.However, during the third inflation at 10 atmospheres for 1 minute, the balloon ruptured, the device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient condition was good.

• 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: 14084295
• Report Number: 2134265-2022-04281
• Device Sequence Number: 12059815
• Product Code: LIT
• UDI-Device Identifier: 08714729181958
• UDI-Public: 08714729181958
• 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): 05/23/2022

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: 08/10/2024
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0027818342
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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