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	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned to the manufacturer.A visual and microscopic examination was done on the outer shaft, inner shaft, balloon and tip.Visual examination revealed no damages.Microscopic examination, however, revealed a pinhole 9mm from the tip.No other damage or irregularities found on the remainder of the device presented.
Event or Problem Description
Reportable based on device analysis completed on 07feb2024.It was reported that balloon leak occurred.The stenosed target lesion was located in the anterior tibial artery.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was used for dilatation.However, during the procedure, the contrast agent was leaking, and the balloon was able to inflate but unable to dilate the lesion.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.However, returned device analysis revealed a pinhole 9mm from the tip.

• 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: 18792712
• Report Number: 2124215-2024-11459
• Device Sequence Number: 15392985
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: 08714729782315
• 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
• Report Date (Section B): 02/27/2024

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: 04/25/2025
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0031503656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• 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: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 45 KG