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	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in an arteriovenous fistula in a mildly tortuous and mildly calcified vein.A sv/5.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.Inflation was performed at 6 atmospheres and 15 atmospheres for 30 seconds respectively.However, during the second inflation, the balloon would not hold pressure.The device was removed and a pinhole was found near the tip of the balloon.The physician noted that it is probable that there was a pinhole during preparation because the negative pressure did not work well.The procedure was completed with another of same device.There were no patient complications reported and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified vein.A sv/5.5-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during second inflation at 15 atmospheres for 30 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications and the patient was stable.
Additional Manufacturer Narrative
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 balloon was subjected to positive pressure.The balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located within the 1mm proximal from the distal markerband.An examination of the balloon material and the tip region identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no damage or issues with the shaft of the device.A visual examination identified no issues with the tip of the device that could have 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: 13245543
• Report Number: 2134265-2022-00133
• Device Sequence Number: 4432201
• Product Code: LIT
• UDI-Device Identifier: 08714729181934
• UDI-Public: 08714729181934
• 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): 02/03/2022

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: 08/30/2024
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0027937851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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