MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a highly calcified vessel in the left lower extremity.A 6.0mmx100mmx135cm sterling balloon catheter was advanced for pre-dilatation.However, during the first inflation before reaching the nominal pressure, the balloon ruptured.The device was completely removed and another 5.0 x40, 135cm charger balloon catheter was advanced for dilatation.However, during the second inflation at 12 atmospheres, the balloon ruptured.The device was completely removed from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8638743
• Report Number: 2134265-2019-05770
• Device Sequence Number: 2211957
• Product Code: DQY
• UDI-Device Identifier: 08714729123682
• UDI-Public: 08714729123682
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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: 10/31/2019
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0019840083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1