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

Model Number	23295
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.: symmetry standard 3.0 - 40/4t/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 balloon pinhole located approximately 1mm distally of the distal marker band.An examination of the balloon material and distal marker band identified no issues.A visual and tactile examination found no kinks or damage to the hypotube of the device.A visual examination identified no damage to the tip of the device.A visual examination identified no damage present in the balloon cones and marker bands.
Event or Problem Description
Reportable based on device analysis completed on 28apr2020.It was reported that balloon inflation failure occurred.The 99% stenosed target lesion was located in an anastomosis shunt in a severely tortuous and moderately calcified vessel.A 3.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the procedure, the balloon failed to inflate despite application of pressure.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed balloon pinhole.

• 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: 10078701
• Report Number: 2134265-2020-05905
• Device Sequence Number: 19538845
• Product Code: LIT
• UDI-Device Identifier: 08714729181675
• UDI-Public: 08714729181675
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2020

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: 05/28/2022
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0023871031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1