MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24703
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that radiopaque marker band was not visible under fluoroscopy.The 70% stenosed target lesion was located in the moderately calcified popliteal artery.A 4.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during procedure, it was noted that the proximal radiopaque marker of the balloon was not visible in fluoroscopy.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9800750
• Report Number: 2134265-2020-02674
• Device Sequence Number: 16847842
• Product Code: DQY
• UDI-Device Identifier: 08714729782377
• UDI-Public: 08714729782377
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K093720
• 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
• Report Date (Section B): 03/06/2020

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: 10/24/2020
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0022846483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1