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	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during the first inflation at 8 atmospheres for 10 seconds, the balloon ruptured and a vertical crack at the tip of the balloon was noted.The device was removed and the procedure was completed with a different device.There were no patient complicaions and the patient was stable.
Additional Manufacturer Narrative
(e1) initial reporter city: (b)(6).Device evaluated by mfr: a symmetry sv/3.5-4/4t/90 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 pinhole in the balloon located within the distal balloon sleeve 3mm distal from the distal markerband.The rated burst pressure for this device is 15 atmospheres as per symmetry product specification.A visual and tactile examination identified the inner shaft was stretched down, distal to the distal edge of the distal markerband.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.5-4/4t/90 symmetry balloon catheter was advanced for dilation.However, during the first inflation at 8 atmospheres for 10 seconds, the balloon ruptured and a vertical crack at the tip of the balloon was noted.The device was removed and the procedure was completed with a different device.There were no patient complications and the patient was stable.It was further reported that the target lesion was located in the moderately tortuous and mildly calcified vessel with 85% stenosis.

• Brand Name: SYMMETRY
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12096067
• Report Number: 2134265-2021-08360
• Device Sequence Number: 11816829
• Product Code: LIT
• UDI-Device Identifier: 08714729181736
• UDI-Public: 08714729181736
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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: 10/28/2022
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0024676746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1