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

Model Number	24702
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 3.0mm x 100mm x 90cm sterling sl balloon catheter was advanced for dilation.However, after reaching the nominal pressure, the balloon part was separated.The procedure was completed with another of the same device and there were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 3.0mm x 100mm x 90cm sterling sl balloon catheter was advanced for dilation.However, after reaching the nominal pressure, the balloon part was separated.The procedure was completed with another of the same device and there were no patient complications nor injuries reported.It was further reported that balloon rupture occurred and no additional intervention performed.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11396283
• Report Number: 2134265-2021-02536
• Device Sequence Number: 11546260
• Product Code: DQY
• UDI-Device Identifier: 08714729782476
• UDI-Public: 08714729782476
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 10/29/2022
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0026270284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: JUPITER; GUIDEWIRE: JUPITER; INTRODUCER SHEATH: TERUMO; INTRODUCER SHEATH: TERUMO