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

Model Number	H74939148251010
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A less than 50% stenosed target lesion was located in a non-tortuous and mildly calcified peroneal artery.A 2.5mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.The radiopaque markers were not at the right spot on the balloon.However, during the first inflation at less than 2 atmospheres for less than 1 second, the balloon ruptured when it was removed.The device was successfully removed from the patient.The procedure was completed with a second balloon.No patient complications were reported.
Additional Manufacturer Narrative
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.A less than 50% stenosed target lesion was located in a non-tortuous and mildly calcified peroneal artery.A 2.5mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.The radiopaque markers were not at the right spot on the balloon.However, during the first inflation at less than 2 atmospheres for less than 1 second, the balloon ruptured when it was removed.The device was successfully removed from the patient.The procedure was completed with a second balloon.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: 18011986
• Report Number: 2124215-2023-57617
• Device Sequence Number: 7277114
• Product Code: DQY
• UDI-Device Identifier: 08714729782254
• UDI-Public: (01)08714729782254(17)250312(10)31221853
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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: 03/12/2025
• Device Model Number: H74939148251010
• Device Catalogue Number: 24702
• Device Lot Number: 0031221853
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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 Sex: Unknown