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	09/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was moderately tortuous and moderately calcified.A sv/5.0-/4t/90 symmetry balloon catheter was advanced for pre-dilation.The device was initially inflated to 15 atmospheres, but the lesion was not fully dilated.A second inflation was performed at 18 atmospheres; however, the balloon ruptured.The device was completely removed and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Returned to manufacturer date- update from 09/25/2018 to 10/01/2018.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was moderately tortuous and moderately calcified.A sv/5.0-/4t/90 symmetry balloon catheter was advanced for pre-dilation.The device was initially inflated to 15 atmospheres, but the lesion was not fully dilated.A second inflation was performed at 18 atmospheres; however, the balloon ruptured.The device was completely removed and the procedure was completed with a different device.No patient complications were reported and the patients status was stable.Device evaluated by manufacturer: the device was returned for analysis.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.A visual and microscopic examination identified a balloon longitudinal tear beginning at the distal end of the proximal markerband and extending approximately 9mm distally across the balloon material.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: 7919376
• Report Number: 2134265-2018-61414
• Device Sequence Number: 1936744
• Product Code: LIT
• UDI-Device Identifier: 08714729181897
• UDI-Public: 08714729181897
• 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,Followup
• Report Date (Section B): 10/25/2018

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: 07/01/2021
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0022325583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1