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

Model Number	23295
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in a shunt in a moderately tortuous and non-calcified vessel in the left hand.A 5.0-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during inflation, the pressure did not rise at all and the usage was stopped.Upon pulling out the device and verified, there was a possibility of a balloon rupture.The procedure was successfully completed with a different device.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in a shunt in a moderately tortuous and non-calcified vessel in the left hand.A 5.0-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during inflation, the pressure did not rise at all and the usage was stopped.Upon pulling out the device and verified, there was a possibility of a balloon rupture.The procedure was successfully completed with a different device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.(e1) initial reporter city: (b)(6).Device evaluated by mfr.: a symmetry device was received 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.A pinhole leak on the surface of the distal balloon bond was identified.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.

• 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: 13733304
• Report Number: 2134265-2022-02298
• Device Sequence Number: 5008887
• Product Code: LIT
• UDI-Device Identifier: 08714729181897
• UDI-Public: 08714729181897
• 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): 04/27/2022

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: 08/17/2024
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0027860629
• 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: 02/18/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• 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: Female