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

Model Number	23335
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
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 located in a shunt in a moderately tortuous and severely calcified vessel.A 3.5-10/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at near 10 atmospheres, the balloon ruptured.Another symmetry device was used to pre-dilate the lesion and the procedure was completed.No patient complications were reported.

• Brand Name: SYMMETRY STIFF SHAFT
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8642895
• Report Number: 2134265-2019-05848
• Device Sequence Number: 16762383
• Product Code: LIT
• UDI-Device Identifier: 08714729182665
• UDI-Public: 08714729182665
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060959
• 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): 05/24/2019

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: 02/28/2022
• Device Model Number: 23335
• Device Catalogue Number: 23335
• Device Lot Number: 0023423681
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1