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

Model Number	24716
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient was being treated for lower limb vessel occlusion and underwent angioplasty.A 3.0x220x90 (4f) sterling balloon catheter was used for dilatation.The device was withdrawn with no resistance.However, upon removal, the shaft broke off completely around the sheath area outside the patient.The procedure was completed successfully with this device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A sterling balloon catheter was returned and the outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is separated 74.1cm from the hub.The guidewire lumen is separated 71.4cm from the hub.There is buckling to the guidewire lumen at the distal end of the separation.Microscopic examination revealed no additional damages.
Event or Problem Description
It was reported that shaft break occurred.The patient was being treated for lower limb vessel occlusion and underwent angioplasty.A 3.0x220x90 (4f) sterling balloon catheter was used for dilatation.The device was withdrawn with no resistance.However, upon removal, the shaft broke off completely around the sheath area outside the patient.The procedure was completed successfully with this device.No patient complications were reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18318776
• Report Number: 2124215-2023-68110
• Device Sequence Number: 15224160
• Product Code: LIT
• UDI-Device Identifier: 08714729860181
• UDI-Public: 08714729860181
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: 08/15/2026
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0032230054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Race: Asian