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

Model Number	24703
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst.Vascular access was obtained via femoral artery with a 6f sheath and a placement of non-boston scientific guidewire.The 85% stenosed target lesion was located in the moderately tortuous lower extremity arterial occlusion.The 6f sheath reached the lesion and determined the angiography.A v-18 hydrophilic wire was advanced with the 2.5mm x 120mm x 150cm sterling sl balloon catheter for dilation.However, the balloon could not dilate and was quickly removed from the patient.The normal saline was used to detect the issue, and found the balloon was bubbling, leaking gas and could not dilate, but no visible pinhole was noted.It was determined that the balloon burst.The procedure was completed with another of the same device.No complications were reported, and the patient's condition following procedure was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination showed multiple kinks along the shaft between 70.5cm-74cm, the microscopic examination revealed two pinholes one at 10.5mm from the tip and the second at 125mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there are two pinholes in the balloon causing the rupture as well as multiple kinks on the shaft.
Event or Problem Description
It was reported that the balloon burst.Vascular access was obtained via femoral artery with a 6f sheath and a placement of non-boston scientific guidewire.The 85% stenosed target lesion was located in the moderately tortuous lower extremity arterial occlusion.The 6f sheath reached the lesion and determined the angiography.A v-18 hydrophilic wire was advanced with the 2.5mm x 120mm x 150cm sterling sl balloon catheter for dilation.However, the balloon could not dilate and was quickly removed from the patient.The normal saline was used to detect the issue, and found the balloon was bubbling, leaking gas and could not dilate, but no visible pinhole was noted.It was determined that the balloon burst.The procedure was completed with another of the same device.No complications were reported, and the patient's condition following procedure was stable.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 20317863
• Report Number: 2124215-2024-60416
• Device Sequence Number: 7862637
• Product Code: DQY
• UDI-Device Identifier: 08714729782261
• UDI-Public: 08714729782261
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093720
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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: 11/19/2025
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0032894793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: V18 CONTROL WIRE; GUIDEWIRE: V18 CONTROL WIRE
• Patient Sex: Male