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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the fourth inflation at 10 atmospheres, the balloon ruptured.The device was removed without any problem and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the sv/4-4/4t/90 symmetry balloon catheter was returned 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 an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon leak located at the proximal balloon bond.A microscopic examination of the balloon material found that the balloon sleeve had completely detached from the proximal balloon bond.As per symmetry specification the rated burst pressure for this device is 15 atmospheres.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found no damage or issues with shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the fourth inflation at 10 atmospheres, the balloon ruptured.The device was removed without any problem and the procedure was completed with another of the same device.There were no patient complications reported.

• 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: 11032747
• Report Number: 2134265-2020-18131
• Device Sequence Number: 13714829
• Product Code: LIT
• UDI-Device Identifier: 08714729181798
• UDI-Public: 08714729181798
• 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): 02/12/2021

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: 09/04/2023
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0025969563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1