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

Model Number	24692
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon failed to inflate due to perforation.A sterling sl balloon was selected for use to pre-dilate intrastent stenosis of the superior mesenteric artery.Once the sterling was positioned within the target lesion, it failed to inflate.The balloon was removed from the patient.Upon inspection, it was determined that the balloon was perforated.The balloon was replaced in order to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that the balloon failed to inflate due to perforation.A sterling sl balloon was selected for use to pre-dilate intrastent stenosis of the superior mesenteric artery.Once the sterling was positioned within the target lesion, it failed to inflate.The balloon was removed from the patient.Upon inspection, it was determined that the balloon was perforated.The balloon was replaced in order to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device analysis: 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 no damages.Microscopic examination revealed a longitudinal tear 47mm from the tip and that was approximately 45mm long.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there was a longitudinal tear 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16400072
• Report Number: 2124215-2023-07106
• Device Sequence Number: 12370481
• Product Code: DQY
• UDI-Device Identifier: 08714729782704
• UDI-Public: 08714729782704
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/19/2023

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: 11/08/2024
• Device Model Number: 24692
• Device Catalogue Number: 24692
• Device Lot Number: 0030510154
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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 Sex: Unknown