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	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon ruptured.A sterling balloon catheter 3.5mm x 150mm, 90cm was selected for use to treat peripheral arterial disease.The target lesion contained 50 percent stenosis.The physician inserted the catheter, and upon treatment of the area the balloon ruptured with a single inflation.It was unknown what the pressure or duration of inflation the balloon was when the rupture occurred.A lasso snare was used to remove balloon fragments successfully.There were no fragments left inside the patient, and the procedure was completed with another balloon without sequalae.
Additional Manufacturer Narrative
Device evaluation by manufacturer: 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 that the balloon was separated 92.2 cm from the hub, and the balloon was pulled over the tip.The guidewire lumen was also separated 78.5 cm from the hub.Microscopic and further inspection of the remainder of the device presented no other damage or irregularities.Product analysis revealed damage to the balloon that confirms the issues reported from the field.
Event or Problem Description
It was reported that the balloon ruptured.A sterling balloon catheter 3.5mm x 150mm, 90cm was selected for use to treat peripheral arterial disease.The target lesion contained 50 percent stenosis.The physician inserted the catheter, and upon treatment of the area the balloon ruptured with a single inflation.It was unknown what the pressure or duration of inflation the balloon was when the rupture occurred.A lasso snare was used to remove balloon fragments successfully.There were no fragments left inside the patient, and the procedure was completed with another balloon without sequalae.

• 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: 16599731
• Report Number: 2124215-2023-13008
• Device Sequence Number: 7324871
• Product Code: DQY
• UDI-Device Identifier: 08714729782537
• UDI-Public: 08714729782537
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2024
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0030106254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown