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	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.A 4.5-4/4t/90 symmetry balloon catheter was selected for use.However, after a non-boston scientific guidewire was inserted into the guidewire lumen of the balloon, a resistance was felt at 40cm from the handle side.It was noted that the balloon catheter was stuck with the guidewire.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a symmetry device was returned for analysis.This symmetry device is recommended for use with guidewire.The customer guidewire was not returned for analysis.During product analysis the investigator was able to load the device on to a boston scientific zipwire with no issues noted.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.No issues were noted which may have potentially contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft of the device.A visual and tactile examination identified no issues with tip of this device.
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.A 4.5-4/4t/90 symmetry balloon catheter was selected for use.However, after a non-boston scientific guidewire was inserted into the guidewire lumen of the balloon, a resistance was felt at 40cm from the handle side.It was noted that the balloon catheter was stuck with the guidewire.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15031030
• Report Number: 2134265-2022-07323
• Device Sequence Number: 19979309
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 01/09/2025
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0028651041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE USED: FUGA.; GUIDEWIRE USED: FUGA.
• Patient Sex: Unknown