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

Model Number	24715
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0x120x150-hybrid sterling balloon catheter was advanced for dilation.However, during inflation at 6 atmospheres in the severely calcified lesion, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9763650
• Report Number: 2134265-2020-02191
• Device Sequence Number: 18958786
• Product Code: LIT
• UDI-Device Identifier: 08714729845423
• UDI-Public: 08714729845423
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• 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): 02/27/2020

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: 03/25/2021
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0024505684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1