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

Model Number	24716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.Two 6.0x220x150-hybrid sterling balloon catheters were used for dilatation.However, during inflation, the balloons ruptured.The procedure was completed with a non-bsc device.No patient complications were reported and the patient was fine.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.Two 6.0x220x150-hybrid sterling balloon catheters were used for dilatation.However, during inflation, the balloons ruptured.The procedure was completed with a non-bsc device.No patient complications were reported and the patient was fine.It was further reported that the lesion was severely calcified and the balloon ruptured during the first inflation at 10 atmospheres for 1 minute.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9203096
• Report Number: 2134265-2019-12586
• Device Sequence Number: 3031875
• Product Code: LIT
• UDI-Device Identifier: 08714729845485
• UDI-Public: 08714729845485
• 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,Followup
• Report Date (Section B): 11/15/2019

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 Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0024133532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1