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

Model Number	24703
Medical Device Problem Codes	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	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel vein.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon rated burst pressure.The device was double wired and removed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the sterling sl was returned for analysis.The returned device was incomplete, the tip and distal marker band were missing.The outer shaft, inner shaft, and balloon were visually and microscopically examined.Visual examination revealed the inner shaft was separated at 11.5cm from the tip.Microscopic examination revealed there was a longitudinal and circumferential burst.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported complaint.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel vein.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon rated burst pressure.The device was double wired and removed.No patient complications were reported.

• 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: 20440885
• Report Number: 2124215-2024-63758
• Device Sequence Number: 12828698
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: 08714729782315
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Followup
• Report Date (Section B): 12/09/2024

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: 05/02/2026
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0033948213
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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 Sex: Unknown