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

Model Number	24703
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 07-feb-2024.It was reported that a balloon leak occurred.The target location was located in the superficial femoral artery occlusion.A 4.0mm x 150mm x 150cm sterling sl balloon catheter was selected for use in dilation.During the procedure, it was observed that the balloon was leaking from the tip upon reaching the target lesion with no complications for the patient.Subsequently, a second balloon was utilized to replace the first one, applying 12atm pressure for 30 seconds.It was evident that the opening of the superficial femoral artery underwent local elastic retraction, and a suspected spiral dissection was noticed at the proximal end.A boston scientific stent was then implanted, followed by post-dilatation within the stent using a mustang balloon at 12atm pressure.The superficial femoral artery remained smooth throughout the process, with no residual stenosis in the stent or extravasation of contrast agent.The distal outflow tract maintained its pre-procedure smoothness.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed a pinhole.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the sterling sl was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 67mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.

• 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: 18826138
• Report Number: 2124215-2024-11883
• Device Sequence Number: 15400239
• Product Code: DQY
• UDI-Device Identifier: 08714729782384
• UDI-Public: 08714729782384
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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: 05/01/2025
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0031533061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 55 KG