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

Model Number	H74939148301010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately calcified and non-tortuous superficial femoral artery.A 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon burst at 6 atmospheres before reaching standard pressure.The device was removed with the guidewire and catheter, and the procedure was completed with another of same device.No patient complications were reported, and patient status was stable.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately calcified and non-tortuous superficial femoral artery.A 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon burst at 6 atmospheres before reaching standard pressure.The device was removed with the guidewire and catheter, and the procedure was completed with another of same device.No patient complications were reported, and patient status was stable.
Additional Manufacturer Narrative
Initial reporter facility name: the second affiliated hospital of guangzhou medical university device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the balloon is separated 10cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Additional Manufacturer Narrative
E1 - (b)(6) hospital.Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the balloon is separated 10cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately calcified and non-tortuous superficial femoral artery.A 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon burst at 6 atmospheres before reaching standard pressure.The device was removed with the guidewire and catheter, and the procedure was completed with another of same device.No patient complications were reported, and patient status 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: 18202893
• Report Number: 2124215-2023-65173
• Device Sequence Number: 17758495
• Product Code: DQY
• UDI-Device Identifier: 08714729782292
• UDI-Public: (01)08714729782292(17)240328(10)29131757
• 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,Followup
• Report Date (Section B): 07/03/2024

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: 03/28/2024
• Device Model Number: H74939148301010
• Device Catalogue Number: 24702
• Device Lot Number: 0029131757
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 01/12/2024; 06/12/2024
• Initial Report FDA Received Date: 11/23/2023
• Supplement Report FDA Received Date: 01/30/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 85 KG