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 Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured occurred.The target lesion was located in a shunt in the moderately tortuous and severely calcified vessel.An sv/3.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, upon the first inflation at 15 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon ruptured occurred.The target lesion was located in a shunt in the moderately tortuous and severely calcified vessel.An sv/3.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, upon the first inflation at 15 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual and microscopic examination found no issue with the profile of the tip of the device that could have potentially contributed to the complaint incident.A visual and microscopic examination found no issue with the profile of the markerbands that could have potentially contributed to the complaint incident.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified blood that was present within the inflation lumen.The device was soaked in a water bath to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located at the distal end of the proximal markerband.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.A visual and tactile examination found no kinks or other damage along the shaft of the device.No other issues were identified during the product analysis.

• 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: 8162144
• Report Number: 2134265-2018-64124
• Device Sequence Number: 13955722
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: 04/02/2021
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0021941353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1