MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Sterling; catheter, percutaneous

Model Number	24716
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter froze on wire occurred.The patient presented with peripheral artery disease (pad).The 80% stenosed lesion was located in a moderately tortuous and moderately calcified popliteal artery.A 5.0 x 220 x 150 sterling balloon catheter was inflated at 6 atmospheres in an.014 non-boston scientific filter guidewire.Following deflation of the balloon, the physician attempted to remove the balloon.However, the balloon would not move and became locked on the wire.The wire appeared bent at the distal end.Both devices were together as one unit.The procedure was completed with another of the same device.No patient complications were reported and the patient fully recovered.

• Brand Name: Sterling
• Common Device Name: catheter, percutaneous
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 17252406
• Report Number: 2124215-2023-32571
• Device Sequence Number: 17819719
• Product Code: LIT
• UDI-Device Identifier: 08714729845409
• UDI-Public: 08714729845409
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 01/04/2026
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0030792780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: Black Or African American