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

Model Number	24690
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The stenosed target lesion was located in the left carotid artery.After a v-18 wire crossed the lesion, a 5.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for dilation.When the device reached the lesion and the physician was adjusting and pressing, it was noted that the delivery shaft was fractured.The device was retrieved with a snare and the procedure was completed with another of the same device.No further patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/20/2018 11:32 am ct.The report number is being corrected from: 2134265-2018-64580 to: 2134265-2018-61930.
Event or Problem Description
It was reported that shaft break occurred.The stenosed target lesion was located in the left carotid artery.After a v-18 wire crossed the lesion, a 5.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for dilation.When the device reached the lesion and the physician was adjusting and pressing, it was noted that the delivery shaft was fractured.The device was retrieved with a snare and the procedure was completed with another of the same device.No further patient complications were reported and the patient's status was stable.Device evaluated by mfr: returned product consisted of a sterling mr balloon catheter.The balloon was loosely folded and there was blood in the balloon and inner lumen.Only 71 cm of the distal end of the device was returned for analysis.The tip, balloon, markerbands and inner/outer sheaths were microscopically and visually inspected.Inspection revealed a separation in the shaft with 47 cm of the shaft was stretched with numerous shaft kinks, tip damage (from being used with a guide wire), inner shaft separated at the port weld/exit notch (25 cm from the tip) and port weld/exit notch damage (ripped).Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7965973
• Report Number: 2134265-2018-61930
• Device Sequence Number: 11121329
• Product Code: DQY
• UDI-Device Identifier: 08714729757122
• UDI-Public: 08714729757122
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0021884846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 09/30/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention