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

Model Number	23295
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device stuck on guidewire occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified shunt vessel.After a v-18 control wire was inserted, a 4.5-4/4t/90 symmetry balloon catheter was advanced for dilation.During the procedure, it was noted that the wire was stuck around the marker on the joint part between the shaft and the balloon catheter.Resistance was encountered upon removal, but the devices were able to be removed as one unit.No fragments left inside the patient.The procedure was completed with this device.No patient complications were reported.
Event or Problem Description
It was reported that device stuck on guidewire occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified shunt vessel.After a v-18 control wire was inserted, a 4.5-4/4t/90 symmetry balloon catheter was advanced for dilation.During the procedure, it was noted that the wire was stuck around the marker on the joint part between the shaft and the balloon catheter.Resistance was encountered upon removal, but the devices were able to be removed as one unit.No fragments left inside the patient.The procedure was completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a symmetry device was received for analysis, during the product analysis the investigator was able to load the device onto a boston scientific 0.018" zipwire without any issue.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.

• 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: 19242706
• Report Number: 2124215-2024-26493
• Device Sequence Number: 17879864
• Product Code: LIT
• UDI-Device Identifier: 08714729181859
• UDI-Public: 08714729181859
• 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): 05/21/2024

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: 03/21/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0029084933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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