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

Model Number	24700
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 04-sep-2018.It was reported that tip damaged occurred.The stenosed target lesion was located in posterior tibial artery.The target lesion was delivered thru a v-18 wire and a non bsc sheath.A 6.0mmx100mmx135cm-hybrid fg sterling otw was used to dilate the lesion.When balloons were attempted, a kink in the catheter near the tip of the balloon was noticed.The procedure was completed with a different device.No patient complications were reported.It was further reported that the returned device analysis revealed a hole in the inner shaft from the tip.Device evaluated by manufacturer: the balloon was loosely folded and there was blood on the balloon.Microscopic examination revealed a hole in the inner shaft 5.5cm from the tip, kinked balloon and inner shaft at 9.7cm from the tip.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7905812
• Report Number: 2134265-2018-61222
• Device Sequence Number: 1484971
• Product Code: DQY
• UDI-Device Identifier: 08714729123682
• UDI-Public: 08714729123682
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/25/2018

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: 04/22/2020
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0020556254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1