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

Model Number	24700
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: estimated date based off the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that a radiopaque marker was missing.A 4.0mm x 40mm x 80 cm sterling balloon was selected for use in a venoplasty procedure.During the procedure, it was noted there was only one radiopaque marker.The procedure was completed with another sterling balloon.There were no patient complications reported.
Additional Manufacturer Narrative
B3 date of event: estimated date based off the aware date as the exact event date was not reported.Device analysis by mfr: the returned product consisted of a sterling balloon catheter.Visual and microscopic inspection confirmed that both markerbands were on the inner shaft within the balloon.There were numerous kinks throughout the shaft.The reported missing markerbands were not confirmed.
Event or Problem Description
It was reported that a radiopaque marker was missing.A 4.0mm x 40mm x 80 cm sterling balloon was selected for use in a venoplasty procedure.During the procedure, it was noted there was only one radiopaque marker.The procedure was completed with another sterling balloon.There were no patient complications 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: 10742014
• Report Number: 2134265-2020-14806
• Device Sequence Number: 3195600
• Product Code: DQY
• UDI-Device Identifier: 08714729123637
• UDI-Public: 08714729123637
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K053116
• 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): 11/23/2020

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: 07/09/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025690442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1