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	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
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 mildly calcified artery.A 7.0mmx40mmx40cm (4f) sterling balloon catheter was advanced for dilation.However, during inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt the moderately tortuous and mildly calcified artery.A 7.0mmx40mmx40cm (4f) sterling balloon catheter was advanced for dilation.However, during inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.It was further reported that another 7.0mmx40mmx40cm (4f) sterling balloon catheter was advanced for dilation; however, during inflation at 6 atmospheres, the balloon also ruptured.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10218754
• Report Number: 2134265-2020-08747
• Device Sequence Number: 16804686
• Product Code: DQY
• UDI-Device Identifier: 08714729124092
• UDI-Public: 08714729124092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• 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): 07/06/2020

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: 03/30/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025422140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1