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

Model Number	H74939148201210
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mid 60¿s male 3 day post op from right superficial femoral artery (sfa) revascularization and stenting.Decreased circulation in the right lower extremity and was taken for procedure: right lower extremity (rle) angiogram, mechanical thrombectomy/plasty.Then end of the balloon was patent and flushed well but the end of the balloon would bunch up and not let the wire go through.The device was not used on the patient, minor delay in procedure.Manufacturer response for catheter, percutaneous, sterling® sl (per site reporter) will obtain.

• Brand Name: STERLING® SL
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 16396100
• Report Number: 16396100
• Device Sequence Number: 20483661
• Product Code: DQY
• UDI-Device Identifier: 08714729782223
• UDI-Public: (01)08714729782223(17)240314(10)29045498
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/10/2023
• Report Date (Section F): 02/10/2023

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 Model Number: H74939148201210
• Device Lot Number: 29045498
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 76 KG
• Date Report Sent to FDA: 02/10/2023