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

Model Number	24690
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that marker band was not visible under fluoroscopy.A 5.0mmx15mmx80cm sterling balloon catheter was advanced for dilation.However, the markers of the balloon was not visible under fluoroscopy.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.There was a ussv balloon catheter inside a guide catheter, separate from the sterling balloon catheter.The sterling was tightly folded with blood in the wire lumen.The sterling device was cut (38mm from the tip) apart for testing during the analysis.The tip, balloon, markerbands and inner/outer shaft were microscopically and visually inspected.Inspection found no damage or irregularities with the device.The markerbands were put under electronic microscope to verify the markerbands were made of gold.There was no evidence of any damage or irregularities contributing to the reported difficulty visualizing the markerbands, which could not be confirmed because the clinical circumstances could not be replicated.
Event or Problem Description
It was reported that marker band was not visible under fluoroscopy.A 5.0mmx15mmx80cm sterling balloon catheter was advanced for dilation.However, the markers of the balloon was not visible under fluoroscopy.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8353408
• Report Number: 2134265-2019-01389
• Device Sequence Number: 1973791
• Product Code: DQY
• UDI-Device Identifier: 08714729757108
• UDI-Public: 08714729757108
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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 Expiration Date: 08/14/2020
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 21011945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1