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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the external iliac artery.A 8.0mmx20mmx135cm sterling balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with a 8mmx40mm sterling balloon catheter.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the external iliac artery.A 8.0mmx20mmx135cm sterling balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with a 8mmx40mm sterling balloon catheter.There were no patient complications nor injuries reported.It was further reported that the balloon ruptured on the second inflation during pre-dilatation.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9690388
• Report Number: 2134265-2020-01224
• Device Sequence Number: 16232042
• Product Code: DQY
• UDI-Device Identifier: 08714729757498
• UDI-Public: 08714729757498
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• 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): 03/02/2020

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: 05/10/2021
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0022109901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1